0A4F4F9BD490A749D5437F821CF06DF1

21 CFR 814

https://www.govinfo.gov/content/pkg/CFR-2015-title21-vol8/pdf/CFR-2015-title21-vol8-part814.pdf

http://leaux.net/URLS/ConvertAPI Text Files/53639E4F972D7463566A46DA736E5929.en.txt

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This file was generated: 2020-07-14 04:49:11

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIndigenousnative3
Politicalstateless personsnation1
HealthDrug Usagedrug33
HealthPhysically Disabledillness2
Healthpatients in emergency situationsemergency situation0
SocialAccess to Social Goodsaccess3
SocialAccess to informationfreedomXofXinformation0
SocialAgeage2
SocialChildchildren1
SocialFetus/Neonateneonates2
SocialIncarceratedrestricted1
SocialMarital Statussingle2
SocialPolice Officerofficer1
SocialProperty Ownershiphome2
SocialThreat of Stigmathreat1
SocialYouth/Minorsminor2
Socialemployeesemployees1
Socialorphanorphan3
Socialphilosophical differences/differences of opinionopinion3
General/OtherPublic Emergencyemergency2
General/OtherRelationship to Authorityauthority4

Political / Indigenous

Searching for indicator native:

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p.000146: investigations involving human subjects. A PMA shall be submitted in six copies each bound in one or
p.000146: more numbered volumes of reasonable size. The applicant shall include informa- tion that it believes to
p.000146: be trade secret or confidential commercial or financial information in all copies of the PMA and identify in
p.000146: at least one copy the in- formation that it believes to be trade secret or confidential commercial or fi- nancial
p.000146: information.
p.000146: (3) A summary in sufficient detail that the reader may gain a general un- derstanding of the data and
p.000146: informa- tion in the application. The summary shall contain the following informa- tion:
p.000146: (i) Indications for use. A general de- scription of the disease or condition the device will diagnose,
p.000146: treat, prevent, cure, or mitigate, including a descrip- tion of the patient population for which
p.000146: the device is intended.
p.000146: (ii) Device description. An explanation of how the device functions, the basic scientific concepts that
p.000146: form the basis
p.000147: 147
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: § 814.20
p.000147: for the device, and the significant physical and performance characteris- tics of the device. A brief
p.000147: description of the manufacturing process should be included if it will significantly enhance the reader’s
p.000147: understanding of the de- vice. The generic name of the device as well as any proprietary name or trade name
p.000147: should be included.
p.000147: (iii) Alternative practices and proce- dures. A description of existing alter- native practices or
p.000147: procedures for diag- nosing, treating, preventing, curing, or mitigating the disease or condition for which the
p.000147: device is intended.
p.000147: (iv) Marketing history. A brief descrip- tion of the foreign and U.S. marketing history, if any, of the device,
p.000147: including a list of all countries in which the de- vice has been marketed and a list of all countries in
p.000147: which the device has been withdrawn from marketing for any rea- son related to the safety or effective- ness
p.000147: of the device. The description shall include the history of the mar- keting of the device by the
p.000147: applicant and, if known, the history of the mar- keting of the device by any other per- son.
p.000147: (v) Summary of studies. An abstract of
p.000147: any information or report described in the PMA under paragraph (b)(8)(ii) of this section and a summary
p.000147: of the re- sults of technical data submitted under paragraph (b)(6) of this section. Such summary shall include
p.000147: a description of the objective of the study, a descrip- tion of the experimental design of the study, a
p.000147: brief description of how the data were collected and analyzed, and a brief description of the results, wheth-
p.000147: er positive, negative, or inconclusive. This section shall include the fol- lowing:
p.000147: (A) A summary of the nonclinical
p.000147: laboratory studies submitted in the ap- plication;
p.000147: (B) A summary of the clinical inves- tigations involving human subjects submitted in the application
p.000147: including a discussion of subject selection and exclusion criteria, study population, study period,
...

p.000157: § 814.80 General.
p.000157: A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that
p.000157: is in- consistent with any conditions to ap- proval specified in the PMA approval order for the device.
p.000157: § 814.82 Postapproval requirements.
p.000157: (a) FDA may impose postapproval re- quirements in a PMA approval order or by regulation at the time of approval
p.000157: of the PMA or by regulation subse- quent to approval. Postapproval re- quirements may include as
p.000157: a condition to approval of the device:
p.000157: (1) Restriction of the sale, distribu- tion, or use of the device as provided by section 515(d)(1)(B)(ii) or
p.000157: 520(e) of the act.
p.000157: (2) Continuing evaluation and peri- odic reporting on the safety, effective- ness, and reliability of
p.000157: the device for its intended use. FDA will state in the PMA approval order the reason or pur- pose for
p.000157: such requirement and the number of patients to be evaluated and the reports required to be submitted.
p.000158: 158
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Food and Drug Administration, HHS § 814.84
p.000158:
p.000158:
p.000158: (3) Prominent display in the labeling of a device and in the advertising of any restricted device of
p.000158: warnings, haz- ards, or precautions important for the device’s safe and effective use, includ- ing patient
p.000158: information, e.g., informa- tion provided to the patient on alter- native modes of therapy and on risks
p.000158: and benefits associated with the use of the device.
p.000158: (4) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on
p.000158: cards given to patients if necessary to protect the public health.
p.000158: (5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace
p.000158: patients if such information is necessary to pro- tect the public health. Under section 519(a)(4) of the
p.000158: act, FDA will require that the identity of any patient be dis- closed in records maintained under this paragraph
p.000158: only to the extent required for the medical welfare of the indi- vidual, to determine the safety
p.000158: or ef- fectiveness of the device, or to verify a record, report, or information sub- mitted to the agency.
p.000158: (6) Maintenance of records for speci-
p.000158: fied periods of time and organization and indexing of records into identifi- able files to enable FDA to
p.000158: determine whether there is reasonable assurance of the continued safety and effective- ness of the device.
p.000158: (7) Submission to FDA at intervals specified in the approval order of peri- odic reports containing
p.000158: the informa- tion required by § 814.84(b).
p.000158: (8) Batch testing of the device.
p.000158: (9) Such other requirements as FDA determines are necessary to provide reasonable assurance, or continued
p.000158: rea- sonable assurance, of the safety and ef- fectiveness of the device.
...

p.000160: § 814.104 Original applications.
p.000160: (a) United States applicant or represent- ative. The applicant or an authorized representative shall sign the
p.000160: HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be
p.000160: countersigned by an authorized representative resid- ing or maintaining a place of business in the United
p.000160: States and shall identify the representative’s name and address.
p.000160: (b) Contents. Unless the applicant jus- tifies an omission in accordance with paragraph (d) of this section,
p.000160: an HDE shall include:
p.000160: (1) A copy of or reference to the de- termination made by FDA’s Office of Orphan Products Development
p.000160: (in ac- cordance with § 814.102) that the device qualifies as a HUD;
p.000160: (2) An explanation of why the device would not be available unless an HDE were granted and a statement
p.000160: that no comparable device (other than another HUD approved under this subpart or a device under an approved
p.000160: IDE) is avail- able to treat or diagnose the disease or condition. The application also shall contain a
p.000160: discussion of the risks and benefits of currently available devices or alternative forms of treatment in
p.000160: the United States;
p.000160: (3) An explanation of why the prob- able benefit to health from the use of the device outweighs the risk
p.000160: of injury or illness from its use, taking into ac- count the probable risks and benefits of currently
p.000160: available devices or alter- native forms of treatment. Such expla- nation shall include a description, ex-
p.000160: planation, or theory of the underlying disease process or condition, and known or postulated
p.000160: mechanism(s) of action of the device in relation to the disease process or condition;
p.000160: (4) All of the information required to be submitted under § 814.20(b), except that:
p.000160: (i) In lieu of the summaries, conclu- sions, and results from clinical inves- tigations
p.000160: required under
p.000160: §§ 814.20(b)(3)(v)(B), (b)(3)(vi), and
p.000160: (b)(6)(ii), the applicant shall include the summaries, conclusions, and re- sults of all clinical
p.000160: experience or inves- tigations (whether adverse or sup- portive) reasonably obtainable by the
p.000161: 161
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: § 814.106
p.000161: applicant that are relevant to an as- sessment of the risks and probable ben- efits of the device; and
p.000161: (ii) In addition to the proposed label- ing requirement set forth in
p.000161: § 814.20(b)(10), the labeling shall bear the following statement: Humanitarian Device. Authorized by Federal
p.000161: law for use in the [treatment or diagnosis] of [specify disease or condition]. The ef- fectiveness of
p.000161: this device for this use has not been demonstrated;
p.000161: (5) The amount to be charged for the device and, if the amount is more than
p.000161: $250, a report by an independent cer- tified public accountant, made in ac- cordance with the Statement on
p.000161: Stand- ards for Attestation established by the American Institute of Certified Public Accountants, or in
...

Political / stateless persons

Searching for indicator nation:

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p.000160: HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be
p.000160: countersigned by an authorized representative resid- ing or maintaining a place of business in the United
p.000160: States and shall identify the representative’s name and address.
p.000160: (b) Contents. Unless the applicant jus- tifies an omission in accordance with paragraph (d) of this section,
p.000160: an HDE shall include:
p.000160: (1) A copy of or reference to the de- termination made by FDA’s Office of Orphan Products Development
p.000160: (in ac- cordance with § 814.102) that the device qualifies as a HUD;
p.000160: (2) An explanation of why the device would not be available unless an HDE were granted and a statement
p.000160: that no comparable device (other than another HUD approved under this subpart or a device under an approved
p.000160: IDE) is avail- able to treat or diagnose the disease or condition. The application also shall contain a
p.000160: discussion of the risks and benefits of currently available devices or alternative forms of treatment in
p.000160: the United States;
p.000160: (3) An explanation of why the prob- able benefit to health from the use of the device outweighs the risk
p.000160: of injury or illness from its use, taking into ac- count the probable risks and benefits of currently
p.000160: available devices or alter- native forms of treatment. Such expla- nation shall include a description, ex-
p.000160: planation, or theory of the underlying disease process or condition, and known or postulated
p.000160: mechanism(s) of action of the device in relation to the disease process or condition;
p.000160: (4) All of the information required to be submitted under § 814.20(b), except that:
p.000160: (i) In lieu of the summaries, conclu- sions, and results from clinical inves- tigations
p.000160: required under
p.000160: §§ 814.20(b)(3)(v)(B), (b)(3)(vi), and
p.000160: (b)(6)(ii), the applicant shall include the summaries, conclusions, and re- sults of all clinical
p.000160: experience or inves- tigations (whether adverse or sup- portive) reasonably obtainable by the
p.000161: 161
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: § 814.106
p.000161: applicant that are relevant to an as- sessment of the risks and probable ben- efits of the device; and
p.000161: (ii) In addition to the proposed label- ing requirement set forth in
p.000161: § 814.20(b)(10), the labeling shall bear the following statement: Humanitarian Device. Authorized by Federal
p.000161: law for use in the [treatment or diagnosis] of [specify disease or condition]. The ef- fectiveness of
p.000161: this device for this use has not been demonstrated;
p.000161: (5) The amount to be charged for the device and, if the amount is more than
p.000161: $250, a report by an independent cer- tified public accountant, made in ac- cordance with the Statement on
p.000161: Stand- ards for Attestation established by the American Institute of Certified Public Accountants, or in
...

Health / Drug Usage

Searching for indicator drug:

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p.000143:
p.000143:
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p.000143:
p.000143:
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p.000143:
p.000143:
p.000143:
p.000143: Food and Drug Administration, HHS § 814.2
p.000143:
p.000143: PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
p.000143: Subpart A—General
p.000143: Sec.
p.000143: 814.1 Scope.
p.000143: 814.2 Purpose.
p.000143: 814.3 Definitions.
p.000143: 814.9 Confidentiality of data and informa- tion in a premarket approval application (PMA) file.
p.000143: 814.15 Research conducted outside the United States.
p.000143: 814.17 Service of orders.
p.000143: 814.19 Product development protocol (PDP).
p.000143: Subpart B—Premarket Approval Application (PMA)
p.000143: 814.20 Application.
p.000143: 814.37 PMA amendments and resubmitted PMAs.
p.000143: 814.39 PMA supplements.
p.000143: Subpart C—FDA Action on a PMA
p.000143: 814.40 Time frames for reviewing a PMA.
p.000143: 814.42 Filing a PMA.
p.000143: 814.44 Procedures for review of a PMA.
p.000143: 814.45 Denial of approval of a PMA.
p.000143: 814.46 Withdrawal of approval of a PMA.
p.000143: 814.47 Temporary suspension of approval of a PMA.
p.000143: Subpart D—Administrative Review
p.000143: [Reserved]
p.000143: Subpart E—Postapproval Requirements
p.000143: 814.80 General.
p.000143: 814.82 Postapproval requirements.
p.000143: 814.84 Reports.
p.000143: Subparts F–G [Reserved]
p.000143: Subpart H—Humanitarian Use Devices
p.000143: 814.100 Purpose and scope.
p.000143: 814.102 Designation of HUD status.
p.000143: 814.104 Original applications.
p.000143: 814.106 HDE amendments and resubmitted HDE’s.
p.000143: 814.108 Supplemental applications.
p.000143: 814.110 New indications for use.
p.000143: 814.112 Filing an HDE.
p.000143: 814.114 Timeframes for reviewing an HDE.
p.000143: 814.116 Procedures for review of an HDE.
p.000143: 814.118 Denial of approval or withdrawal of approval of an HDE.
p.000143: 814.120 Temporary suspension of approval of an HDE.
p.000143: 814.122 Confidentiality of data and informa- tion.
p.000143: 814.124 Institutional Review Board require- ments.
p.000143:
p.000143: 814.126 Postapproval requirements and re- ports.
p.000143: AUTHORITY: 21 U.S.C. 351, 352, 353, 360, 360c–
p.000143: 360j, 371, 372, 373, 374, 375, 379, 379e, 381.
p.000143: SOURCE: 51 FR 26364, July 22, 1986, unless
p.000143: otherwise noted.
p.000143:
p.000143: Subpart A—General
p.000143: § 814.1 Scope.
p.000143: (a) This section implements sections
p.000143: 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended
p.000143: for human use.
p.000143: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000143: title 21, unless otherwise noted.
p.000143: (c) This part applies to any class III medical device, unless exempt under section 520(g) of the act,
p.000143: that:
p.000143: (1) Was not on the market (intro- duced or delivered for introduction into commerce for commercial
p.000143: distribution) before May 28, 1976, and is not substan- tially equivalent to a device on the market before
p.000143: May 28, 1976, or to a de- vice first marketed on, or after that date, which has been classified
p.000143: into class I or class II; or
p.000143: (2) Is required to have an approved premarket approval application (PMA) or a declared completed product
p.000143: devel- opment protocol under a regulation issued under section 515(b) of the act; or
p.000143: (3) Was regulated by FDA as a new drug or antibiotic drug before May 28, 1976, and therefore is
p.000143: governed by sec- tion 520(1) of the act.
p.000143: (d) This part amends the conditions to approval for any PMA approved be- fore the effective date of this
p.000143: part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any
p.000143: condition to approval for an approved PMA that is consistent with this part remains in effect.
p.000143: [51 FR 26364, July 22, 1986, as amended at 79
p.000143: FR 1740, Jan. 10, 2014]
p.000143: § 814.2 Purpose.
p.000143: The purpose of this part is to estab- lish an efficient and thorough device review process—
p.000143: (a) To facilitate the approval of PMA’s for devices that have been
p.000143: 143
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: § 814.3
p.000143: shown to be safe and effective and that otherwise meet the statutory criteria for approval; and
p.000143: (b) To ensure the disapproval of PMA’s for devices that have not been shown to be safe and
p.000143: effective or that do not otherwise meet the statutory criteria for approval. This part shall be construed in
p.000143: light of these objectives.
p.000143: § 814.3 Definitions.
p.000143: For the purposes of this part:
p.000143: (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201– 902, 52 Stat. 1040 et seq., as
p.000143: amended (21
p.000143: U.S.C. 321–392)).
p.000143: (b) FDA means the Food and Drug Administration.
p.000143: (c) IDE means an approved or consid- ered approved investigational device exemption under section 520(g) of
p.000143: the act and parts 812 and 813.
p.000143: (d) Master file means a reference source that a person submits to FDA. A master file may contain detailed
p.000143: infor- mation on a specific manufacturing fa- cility, process, methodology, or compo- nent used in the
p.000143: manufacture, proc- essing, or packaging of a medical de- vice.
p.000143: (e) PMA means any premarket ap- proval application for a class III med- ical device, including all
p.000143: information submitted with or incorporated by ref- erence therein. ‘‘PMA’’ includes a new drug application
p.000143: for a device under sec- tion 520(1) of the act.
p.000143: (f) PMA amendment means informa- tion an applicant submits to FDA to modify a pending PMA or a
p.000143: pending PMA supplement.
p.000143: (g) PMA supplement means a supple- mental application to an approved PMA for approval of a change or
p.000143: modi- fication in a class III medical device, including all information submitted with or
p.000143: incorporated by reference therein.
p.000143: (h) Person includes any individual, partnership, corporation, association, scientific or academic
p.000143: establishment, Government agency, or organizational unit thereof, or any other legal entity.
p.000143: (i) Statement of material fact means a representation that tends to show that the safety or effectiveness
p.000143: of a device is more probable than it would be in the absence of such a representation. A false affirmation or
p.000143: silence or an omis-
p.000143: 21 CFR Ch. I (4–1–15 Edition)
p.000143: sion that would lead a reasonable per- son to draw a particular conclusion as to the safety or
p.000143: effectiveness of a de- vice also may be a false statement of material fact, even if the statement
p.000143: was not intended by the person making it to be misleading or to have any pro- bative effect.
p.000143: (j) 30-day PMA supplement means a supplemental application to an ap- proved PMA in
p.000143: accordance with
p.000143: § 814.39(e).
p.000143: (k) Reasonable probability means that it is more likely than not that an event will occur.
p.000143: (l) Serious, adverse health consequences means any significant adverse experi- ence, including those which
p.000143: may be ei- ther life-threatening or involve perma- nent or long term injuries, but exclud- ing injuries
p.000143: that are nonlife-threat- ening and that are temporary and rea- sonably reversible.
p.000143: (m) HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device
p.000143: exemption from the effectiveness re- quirements of sections 514 and 515 of the act as authorized
p.000143: by section 520(m)(2) of the act.
p.000143: (n) HUD (humanitarian use device) means a medical device intended to benefit patients in the
p.000143: treatment or di- agnosis of a disease or condition that affects or is manifested in fewer than 4,000
p.000143: individuals in the United States per year.
p.000143: (o) Ne ly acquired information means data, analyses, or other information not previously submitted to
p.000143: the agen- cy, which may include (but are not lim- ited to) data derived from new clinical studies, reports of
p.000143: adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the stud- ies, events
p.000143: or analyses reveal risks of a different type or greater severity or frequency than previously included in
p.000143: submissions to FDA.
p.000143: (p) Human cell, tissue, or cellular or tis- sue-based product (HCT/P) regulated as a device means an HCT/P as
p.000143: defined in
p.000143: § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a
p.000143: device.
p.000143: (q) Unique device identifier (UDI)
p.000143: means an identifier that adequately
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p.000144:
p.000144: Food and Drug Administration, HHS § 814.9
p.000144:
p.000144:
p.000144: identifies a device through its distribu- tion and use by meeting the require- ments of § 830.20 of this
p.000144: chapter. A unique device identifier is composed of:
p.000144: (1) A device identifier—a mandatory, fixed portion of a UDI that identifies the specific version or
p.000144: model of a de- vice and the labeler of that device; and
p.000144: (2) A production identifier—a condi- tional, variable portion of a UDI that identifies one or more of
p.000144: the following when included on the label of the de- vice:
p.000144: (i) The lot or batch within which a device was manufactured;
p.000144: (ii) The serial number of a specific device;
p.000144: (iii) The expiration date of a specific device;
p.000144: (iv) The date a specific device was manufactured.
p.000144: (v) For an HCT/P regulated as a de- vice, the distinct identification code required by § 1271.290(c) of
p.000144: this chapter.
p.000144: (r) Universal product code (UPC) means the product identifier used to identify an item sold at
p.000144: retail in the United States.
p.000144: (s) Pediatric patients means patients who are 21 years of age or younger (that is, from birth
p.000144: through the twen- ty-first year of life, up to but not in- cluding the twenty-second birthday) at the time of
p.000144: the diagnosis or treatment.
p.000144: (t) Readily available means available in the public domain through com- monly used public resources
p.000144: for con- ducting biomedical, regulatory, and medical product research.
p.000144: [51 FR 26364, July 22, 1986, as amended at 61
...

p.000144: the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under
p.000144: § 814.82, any master file, or any other related submission. Any record in the PMA file will be available
p.000144: for public disclosure in accordance with the pro- visions of this section and part 20. The
p.000144: confidentiality of information in a
p.000144:
p.000144: color additive petition submitted as part of a PMA is governed by § 71.15.
p.000144: (b) The existence of a PMA file may not be disclosed by FDA before an ap- proval order is issued to
p.000144: the applicant unless it previously has been publicly disclosed or acknowledged.
p.000144: (c) If the existence of a PMA file has not been publicly disclosed or acknowl- edged, data or information in
p.000144: the PMA file are not available for public disclo- sure.
p.000144: (d)(1) If the existence of a PMA file has been publicly disclosed or acknowl- edged before an order
p.000144: approving, or an order denying approval of the PMA is issued, data or information contained in the file
p.000144: are not available for public disclosure before such order issues. FDA may, however, disclose a
p.000144: sum- mary of portions of the safety and ef- fectiveness data before an approval order or an order
p.000144: denying approval of the PMA issues if disclosure is relevant to public consideration of a specific pending
p.000144: issue.
p.000144: (2) Notwithstanding paragraph (d)(1) of this section, FDA will make avail- able to the public upon
p.000144: request the in- formation in the IDE that was required to be filed in Docket Number 95S–0158 in the Division of
p.000144: Dockets Management (HFA–305), Food and Drug Administra- tion, 12420 Parklawn Dr., rm. 1–23, Rockville,
p.000144: MD 20857, for investigations involving an exception from informed consent under § 50.24 of this
p.000144: chapter. Persons wishing to request this infor- mation shall submit a request under the Freedom of
p.000144: Information Act.
p.000144: (e) Upon issuance of an order approv- ing, or an order denying approval of any PMA, FDA will make available
p.000144: to the public the fact of the existence of the PMA and a detailed summary of in- formation submitted to FDA
p.000144: respect- ing the safety and effectiveness of the device that is the subject of the PMA and that is the
p.000144: basis for the order.
p.000144: (f) After FDA issues an order approv- ing, or an order denying approval of any PMA, the following data and infor-
p.000144: mation in the PMA file are imme- diately available for public disclosure:
p.000144: (1) All safety and effectiveness data and information previously disclosed to the public, as such disclosure is
p.000144: defined in § 20.81.
p.000145: 145
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: § 814.15
p.000145: (2) Any protocol for a test or study unless the protocol is shown to con- stitute trade secret or
p.000145: confidential commercial or financial information under § 20.61.
p.000145: (3) Any adverse reaction report, prod- uct experience report, consumer com- plaint, and other similar data and
p.000145: in- formation, after deletion of:
p.000145: (i) Any information that constitutes trade secret or confidential commer- cial or financial
p.000145: information under
p.000145: § 20.61; and
...

p.000145: device for which a PMA has been abandoned and they no longer represent a trade secret or con-
p.000145: fidential commercial or financial infor- mation as defined in § 20.61:
p.000145: (1) Manufacturing methods or proc-
p.000145: esses, including quality control proce- dures.
p.000145: (2) Production, sales, distribution, and similar data and information, ex- cept that any compilation of such
p.000145: data and information aggregated and pre- pared in a way that does not reveal data or information
p.000145: which are not available for public disclosure under this provision is available for public
p.000145: disclosure.
p.000145: (3) Quantitative or semiquantitative
p.000145: formulas.
p.000145: [51 FR 26364, July 22, 1986, as amended at 61
p.000145: FR 51531, Oct. 2, 1996]
p.000145:
p.000145: § 814.15 Research conducted outside the United States.
p.000145: (a) A study conducted outside the United States submitted in support of a PMA and conducted under
p.000145: an IDE shall comply with part 812. A study conducted outside the United States submitted in
p.000145: support of a PMA and not conducted under an IDE shall comply with the provisions in paragraph (b) or
p.000145: (c) of this section, as applicable.
p.000145: (b) Research begun on or after effective date. FDA will accept studies sub- mitted in support of a PMA
p.000145: which have been conducted outside the United States and begun on or after November 19, 1986, if the data
p.000145: are valid and the in- vestigator has conducted the studies in
p.000146: 146
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146: Food and Drug Administration, HHS § 814.20
p.000146:
p.000146:
p.000146: conformance with the ‘‘Declaration of Helsinki’’ or the laws and regulations of the country in which the
p.000146: research is conducted, whichever accords greater protection to the human subjects. If the standards
p.000146: of the country are used, the applicant shall state in detail any differences between those standards
p.000146: and the ‘‘Declaration of Helsinki’’ and explain why they offer greater protec- tion to the human subjects.
p.000146: (c) Research begun before effective date. FDA will accept studies sub- mitted in support of a PMA
p.000146: which have been conducted outside the United States and begun before November 19, 1986, if FDA is
p.000146: satisfied that the data are scientifically valid and that the rights, safety, and welfare of
p.000146: human subjects have not been violated.
p.000146: (d) As sole basis for marketing approval. A PMA based solely on foreign clinical data and otherwise meeting the
p.000146: cri- teria for approval under this part may be approved if:
p.000146: (1) The foreign data are applicable to the U.S. population and U.S. medical practice;
p.000146: (2) The studies have been performed by clinical investigators of recognized competence; and
p.000146: (3) The data may be considered valid without the need for an on-site inspec- tion by FDA or, if FDA
p.000146: considers such an inspection to be necessary, FDA can validate the data through an on-site in- spection or other
p.000146: appropriate means.
...

p.000147: in the appli- cation constitute valid scientific evi- dence within the meaning of § 860.7 and provide reasonable
p.000147: assurance that the device is safe and effective for its in- tended use. A concluding discussion shall
p.000147: present benefit and risk consider- ations related to the device including a discussion of any adverse effects of the
p.000147: device on health and any proposed ad- ditional studies or surveillance the ap- plicant intends to
p.000147: conduct following approval of the PMA.
p.000147: (4) A complete description of:
p.000147: (i) The device, including pictorial representations;
p.000147: (ii) Each of the functional compo- nents or ingredients of the device if the device consists of more than
p.000147: one phys- ical component or ingredient;
p.000147: (iii) The properties of the device rel- evant to the diagnosis, treatment, pre- vention, cure, or
p.000147: mitigation of a dis- ease or condition;
p.000147: (iv) The principles of operation of the device; and
p.000147: (v) The methods used in, and the fa- cilities and controls used for, the man- ufacture, processing, packing,
p.000147: storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally
p.000147: familiar with current good manufacturing practice can make a knowledgeable judgment about the quality
p.000147: control used in the manufac- ture of the device.
p.000147: (5) Reference to any performance standard under section 514 of the act or under section 534 of
p.000147: Subchapter C— Electronic Product Radiation Control of the Federal Food, Drug, and Cos- metic Act
p.000147: (formerly the Radiation Control for Health and Safety Act of 1968) in effect or proposed at the time
p.000147: of the submission and to any voluntary standard that is relevant to any aspect of the safety or effectiveness of the
p.000147: de- vice and that is known to or that should reasonably be known to the ap- plicant. The applicant
p.000147: shall—
p.000147: (i) Provide adequate information to
p.000147: demonstrate how the device meets, or
p.000148: 148
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Food and Drug Administration, HHS § 814.20
p.000148:
p.000148:
p.000148: justify any deviation from, any per- formance standard established under section 514 of the act or
p.000148: under section
p.000148: 534 of Subchapter C—Electronic Prod- uct Radiation Control of the Federal Food, Drug, and Cosmetic Act
p.000148: (for- merly the Radiation Control for Health and Safety Act of 1968), and
p.000148: (ii) Explain any deviation from a vol- untary standard.
p.000148: (6) The following technical sections which shall contain data and informa- tion in sufficient detail to permit
p.000148: FDA to determine whether to approve or deny approval of the application:
p.000148: (i) A section containing results of the nonclinical laboratory studies with the device including microbiological,
p.000148: toxi- cological, immunological, biocompat- ibility, stress, wear, shelf life, and other laboratory or
p.000148: animal tests as ap- propriate. Information on nonclinical laboratory studies shall include a
p.000148: statement that each such study was conducted in compliance with part 58, or, if the study was not
p.000148: conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
p.000148: (ii) A section containing results of
p.000148: the clinical investigations involving human subjects with the device includ- ing clinical protocols, number of
p.000148: inves- tigators and subjects per investigator, subject selection and exclusion cri- teria, study
p.000148: population, study period, safety and effectiveness data, adverse reactions and complications, patient
p.000148: discontinuation, patient complaints, device failures and replacements, tab- ulations of data from all
p.000148: individual subject report forms and copies of such forms for each subject who died during a clinical investigation
p.000148: or who did not complete the investigation, results of statistical analyses of the clinical in-
p.000148: vestigations, device failures and re- placements, contraindications and pre- cautions for use of the
...

p.000149: three copies of any update report and shall include in the report the number assigned by FDA to the PMA.
p.000149: These updates are consid- ered to be amendments to the PMA. The time frame for review of a PMA will not
p.000149: be extended due to the submis- sion of an update report unless the up- date is a major amendment under
p.000149: § 814.37(c)(1). The applicant shall submit
p.000149: these reports—
p.000149: (1) 3 months after the filing date,
p.000149: (2) Following receipt of an approv- able letter, and
p.000149: (3) At any other time as requested by FDA.
p.000149: (f) If a color additive subject to sec- tion 721 of the act is used in or on the device and has not
p.000149: previously been list- ed for such use, then, in lieu of submit- ting a color additive petition under part
p.000149: 71, at the option of the applicant, the information required to be sub- mitted under part 71 may be
p.000149: submitted as part of the PMA. When submitted as part of the PMA, the information shall be submitted in three
p.000149: copies each bound in one or more numbered vol- umes of reasonable size. A PMA for a device that
p.000149: contains a color additive that is subject to section 721 of the act will not be approved until the color ad- ditive
p.000149: is listed for use in or on the de- vice.
p.000149: (g) Additional information on FDA
p.000149: policies and procedures, as well as links to PMA guidance documents, is available on the Internet
p.000149: at http://
p.000149: .fda.gov/MedicalDevices/ DeviceRegulationandGuidance/
p.000150: 150
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150: Food and Drug Administration, HHS § 814.37
p.000150:
p.000150:
p.000150: Ho toMarketYourDevice/ PremarketSubmissions/ PremarketApprovalPMA/default.htm.
p.000150: (h) If you are sending a PMA, PMA amendment, PMA supplement, or cor- respondence with respect to a
p.000150: PMA, you must send the submission to the appropriate address as follows:
p.000150: (1) For devices regulated by the Cen- ter for Devices and Radiological Health, Food and Drug
p.000150: Administration, Center for Devices and Radiological Health, Document Mail Center, 10903 New Hampshire
p.000150: Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993–0002.
p.000150: (2) For devices regulated by the Cen- ter for Biologics Evaluation and Re- search, send it to:
p.000150: Document Control Center (HFM–99), Center for Biologics Evaluation and Research, Food and Drug
p.000150: Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852– 1448.
p.000150: (3) For devices regulated by the Cen- ter for Drug Evaluation and Research, send it to: Central Document
p.000150: Control Room, Center for Drug Evaluation and Research, Food and Drug Administra- tion, 5901–B Ammendale Rd.,
p.000150: Beltsville, MD 20705–1266.
p.000150: [51 FR 26364, July 22, 1986; 51 FR 40415, Nov.
p.000150: 7, 1986, as amended at 51 FR 43344, Dec. 2,
p.000150: 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600,
p.000150: July 29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR
p.000150: 17137, Mar. 31, 2000; 65 FR 56480, Sept. 19, 2000;
p.000150: 67 FR 9587, Mar. 4, 2002; 71 FR 42048, July 25,
p.000150: 2006; 72 FR 17399, Apr. 9, 2007; 73 FR 34859,
p.000150: June 19, 2008; 74 FR 14478, Mar. 31, 2009; 75 FR
p.000150: 20915, Apr. 22, 2010; 78 FR 18233, Mar. 26, 2013;
p.000150: 79 FR 1740, Jan. 10, 2014]
p.000150:
p.000150: § 814.37 PMA amendments and resub- mitted PMAs.
p.000150: (a) An applicant may amend a pend- ing PMA or PMA supplement to revise existing information or provide
p.000150: addi- tional information.
p.000150: (b)(1) FDA may request the applicant to amend a PMA or PMA supplement with any information regarding the de- vice
p.000150: that is necessary for FDA or the appropriate advisory committee to complete the review of the
p.000150: PMA or PMA supplement.
p.000150: (2) FDA may request the applicant to amend a PMA or PMA supplement with information concerning pediatric uses as
p.000150: required under §§ 814.20(b)(13) and 814.39(c)(2).
p.000150:
p.000150: (c) A PMA amendment submitted to FDA shall include the PMA or PMA supplement number assigned to the
p.000150: original submission and, if submitted on the applicant’s own initiative, the reason for submitting the
p.000150: amendment. FDA may extend the time required for its review of the PMA, or PMA supple- ment, as follows:
p.000150: (1) If the applicant on its own initia- tive or at FDA’s request submits a major PMA
...

p.000151: time frames for review of, and FDA action on, a PMA supplement are the same as those pro- vided in §
p.000151: 814.40 for a PMA.
p.000151: (2) The supplement must include the
p.000151: following information:
p.000151: (i) Information concerning pediatric uses as required under § 814.20(b)(13).
p.000151: (ii) If information concerning the de- vice that is the subject of the supple- ment was previously submitted
p.000151: under
p.000151: § 814.20(b)(13) or under this section in a previous supplement, that information may be included by
p.000151: referencing a pre- vious application or submission that contains the information. However, if additional
p.000151: information required under
p.000151: § 814.20(b)(13) has become readily avail- able to the applicant since the previous submission, the applicant
p.000151: must submit that information as part of the supple- ment.
p.000151: (d)(1) After FDA approves a PMA, any change described in paragraph (d)(2) of this section to
p.000151: reflect newly acquired information that enhances the safety of the device or the safety in the use of the
p.000151: device may be placed into effect by the applicant prior to the receipt under § 814.17 of a written FDA order
p.000151: approving the PMA supplement provided that:
p.000151: (i) The PMA supplement and its mail- ing cover are plainly marked ‘‘Special PMA Supplement—Changes Being Ef-
p.000151: fected’’;
p.000151: (ii) The PMA supplement provides a full explanation of the basis for the changes;
p.000152: 152
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152: Food and Drug Administration, HHS § 814.40
p.000152:
p.000152:
p.000152: (iii) The applicant has received ac- knowledgement from FDA of receipt of the supplement; and
p.000152: (iv) The PMA supplement specifically identifies the date that such changes are being effected.
p.000152: (2) The following changes are per- mitted by paragraph (d)(1) of this sec- tion:
p.000152: (i) Labeling changes that add or strengthen a contraindication, warn- ing, precaution, or
p.000152: information about an adverse reaction for which there is reasonable evidence of a causal asso- ciation.
p.000152: (ii) Labeling changes that add or strengthen an instruction that is in- tended to enhance the safe
p.000152: use of the device.
p.000152: (iii) Labeling changes that delete misleading, false, or unsupported indi- cations.
p.000152: (iv) Changes in quality controls or manufacturing process that add a new specification or test method, or
p.000152: other- wise provide additional assurance of purity, identity, strength, or reli- ability of the
p.000152: device.
p.000152: (e)(1) FDA will identify a change to a device for which an applicant has an approved PMA and for which a
p.000152: PMA supplement under paragraph (a) is not required. FDA will identify such a change in an advisory
p.000152: opinion under
p.000152: § 10.85, if the change applies to a ge- neric type of device, or in correspond- ence to the applicant, if
p.000152: the change ap- plies only to the applicant’s device. FDA will require that a change for which a
p.000152: PMA supplement under para- graph (a) is not required be reported to FDA in:
...

p.000153: agency will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in
p.000153: the applica- tion that prevent filing and will in- clude the PMA reference number.
p.000153: (d) If FDA refuses to file the PMA, the applicant may:
p.000153: (1) Resubmit the PMA with addi- tional information necessary to comply with the requirements of
p.000153: section 515(c)(1) (A)–(G) of the act and § 814.20. A resubmitted PMA shall include the PMA reference
p.000153: number of the original submission. If the resubmitted PMA is accepted for filing, the date of filing is the
p.000153: date FDA receives the resubmis- sion;
p.000153: (2) Request in writing within 10
p.000153: working days of the date of receipt of
p.000153: 21 CFR Ch. I (4–1–15 Edition)
p.000153: the notice refusing to file the PMA, an informal conference with the Director of the Office of Device
p.000153: Evaluation to review FDA’s decision not to file the PMA. FDA will hold the informal con- ference within
p.000153: 10 working days of its receipt of the request and will render its decision on filing within 5 working
p.000153: days after the informal conference. If, after the informal conference, FDA ac- cepts the PMA for filing,
p.000153: the date of filing will be the date of the decision to accept the PMA for filing. If FDA does not reverse
p.000153: its decision not to file the PMA, the applicant may request recon- sideration of the decision from the Di-
p.000153: rector of the Center for Devices and Radiological Health, the Director of the Center for Biologics
p.000153: Evaluation and Research, or the Director of the Center for Drug Evaluation and Re- search, as
p.000153: applicable. The Director’s decision will constitute final adminis- trative action for the purpose of
p.000153: judi- cial review.
p.000153: (e) FDA may refuse to file a PMA if any of the following applies:
p.000153: (1) The application is incomplete be- cause it does not on its face contain all the information required under
p.000153: section 515(c)(1) (A)–(G) of the act;
p.000153: (2) The PMA does not contain each of the items required under § 814.20 and justification for omission of
p.000153: any item is inadequate;
p.000153: (3) The applicant has a pending pre- market notification under section 510(k) of the act with
p.000153: respect to the same device, and FDA has not deter- mined whether the device falls within the scope of §
p.000153: 814.1(c).
p.000153: (4) The PMA contains a false state- ment of material fact.
p.000153: (5) The PMA is not accompanied by a statement of either certification or dis- closure as required by part 54 of
p.000153: this chapter.
p.000153: [51 FR 26364, July 22, 1986, as amended at 63
p.000153: FR 5254, Feb. 2, 1998; 73 FR 49942, Aug. 25,
p.000153: 2008]
p.000153:
p.000153: § 814.44 Procedures for review of a PMA.
p.000153: (a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42. FDA may refer the
p.000153: PMA to a panel on its own initiative, and will do so upon request of an appli- cant, unless FDA determines
p.000153: that the
p.000154: 154
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Food and Drug Administration, HHS § 814.44
p.000154:
p.000154:
p.000154: application substantially duplicates in- formation previously reviewed by a panel. If FDA refers an application
p.000154: to a panel, FDA will forward the PMA, or relevant portions thereof, to each member of the
p.000154: appropriate FDA panel for review. During the review process, FDA may communicate with the appli- cant as set
p.000154: forth under § 814.37(b), or with a panel to respond to questions that may be posed by panel members or to
p.000154: provide additional information to the panel. FDA will maintain a record of all communications with the
p.000154: appli- cant and with the panel.
p.000154: (b) The advisory committee shall
p.000154: submit a report to FDA which includes the committee’s recommendation and the basis for such recommendation on
p.000154: the PMA. Before submission of this re- port, the committee shall hold a public meeting to review the PMA in
p.000154: accord- ance with part 14. This meeting may be held by a telephone conference under
p.000154: § 14.22(g). The advisory committee re- port and recommendation may be in the form of a meeting transcript
p.000154: signed by the chairperson of the committee.
p.000154: (c) FDA will complete its review of the PMA and the advisory committee report and recommendation and,
p.000154: with- in the later of 180 days from the date of filing of the PMA under § 814.42 or the number of days after
p.000154: the date of filing as determined under § 814.37(c), issue an approval order under paragraph (d) of this
p.000154: section, an approvable letter under paragraph (e) of this section, a not ap- provable letter under paragraph
...

p.000154: in the draft final labeling. Such ap- proval will be conditioned upon the ap- plicant incorporating the
p.000154: specified la- beling changes exactly as directed and upon the applicant submitting to FDA a copy of the
p.000154: final printed labeling be- fore marketing. FDA will also give the public notice of the order, including
p.000154: notice of and opportunity for any in-
p.000154:
p.000154: terested persons to request review under section 515(d)(3) of the act. The notice of approval
p.000154: will be placed on FDA’s home page on the Internet (http:// .fda.gov), and it will
p.000154: state that a detailed summary of informa- tion respecting the safety and effec- tiveness of the
p.000154: device, which was the basis for the order approving the PMA, including information about any ad- verse
p.000154: effects of the device on health, is available on the Internet and has been placed on public display, and
p.000154: that cop- ies are available upon request. FDA will publish in the FEDERAL REGISTER after each quarter
p.000154: a list of the approv- als announced in that quarter. When a notice of approval is published, data
p.000154: and information in the PMA file will be available for public disclosure in ac- cordance with § 814.9.
p.000154: (2) A request for copies of the current PMA approvals and denials document and for copies of summaries of
p.000154: safety and effectiveness shall be sent in writ- ing to the Division of Dockets Manage- ment (HFA–305), Food
p.000154: and Drug Ad- ministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
p.000154: (e) FDA will send the applicant an approvable letter if the application substantially meets the
p.000154: requirements of this part and the agency believes it can approve the application if specific additional
p.000154: information is submitted or specific conditions are agreed to by the applicant.
p.000154: (1) The approvable letter will de- scribe the information FDA requires to be provided by the
p.000154: applicant or the conditions the applicant is required to meet to obtain approval. For example, FDA may
p.000154: require, as a condition to ap- proval:
p.000154: (i) The submission of certain infor- mation identified in the approvable let- ter, e.g., final labeling;
p.000154: (ii) The submission of additional in- formation concerning pediatric uses re- quired by § 814.20(b)(13);
p.000154: (iii) An FDA inspection that finds the manufacturing facilities, methods, and controls in compliance with part
p.000154: 820 and, if applicable, that verifies records pertinent to the PMA;
p.000154: (iv) Restrictions imposed on the de- vice under section 515(d)(1)(B)(ii) or 520(e) of the act;
p.000155: 155
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: § 814.45
p.000155: (v) Postapproval requirements as de- scribed in subpart E of this part.
p.000155: (2) In response to an approvable let- ter the applicant may:
p.000155: (i) Amend the PMA as requested in the approvable letter; or
p.000155: (ii) Consider the approvable letter to be a denial of approval of the PMA under § 814.45 and
p.000155: request administra- tive review under section 515(d)(3) of the act by filing a petition in the form of a
p.000155: petition for reconsideration under
...

p.000155: and verify all records per- tinent to the application;
p.000155: (4) A nonclinical laboratory study that is described in the PMA and that is essential to show that
p.000155: the device is safe for use under the conditions pre- scribed, recommended, or suggested in its proposed
p.000155: labeling, was not con- ducted in compliance with the good laboratory practice regulations in part
p.000155: 58 and no reason for the noncompliance is provided or, if it is, the differences between the practices
p.000155: used in con- ducting the study and the good labora- tory practice regulations do not sup- port the validity of
p.000155: the study; or
p.000155: (5) Any clinical investigation involv- ing human subjects described in the PMA, subject to the
p.000155: institutional re- view board regulations in part 56 or in- formed consent regulations in part 50, was not
p.000155: conducted in compliance with those regulations such that the rights or safety of human subjects were not
p.000155: adequately protected.
p.000155: (b) FDA will issue any order denying approval of the PMA in accordance with § 814.17. The order
p.000155: will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under
p.000155: section 515(d)(2) of the act and the regulations under this part, and, where practical, will identify
p.000155: measures required to place the PMA in approvable form. The order will include a notice of an opportunity to
p.000155: request review under section 515(d)(4) of the act.
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: Food and Drug Administration, HHS § 814.46
p.000156:
p.000156:
p.000156: (c) FDA will use the criteria specified in § 860.7 to determine the safety and effectiveness of a device
p.000156: in deciding whether to approve or deny approval of a PMA. FDA may use information other than that submitted
p.000156: by the appli- cant in making such determination.
p.000156: (d)(1) FDA will give the public notice of an order denying approval of the PMA. The notice will be
p.000156: placed on the FDA’s home page on the Internet (http:// .fda.gov), and it will state
p.000156: that a detailed summary of informa- tion respecting the safety and effec- tiveness of the device,
p.000156: including infor- mation about any adverse effects of the device on health, is available on the Internet and
p.000156: has been placed on public display and that copies are available upon request. FDA will publish in the
p.000156: FEDERAL REGISTER after each quarter a list of the denials announced in that quarter. When a notice of
p.000156: denial of ap- proval is made publicly available, data and information in the PMA file will be available for
p.000156: public disclosure in ac- cordance with § 814.9.
p.000156: (2) A request for copies of the current PMA approvals and denials document and copies of summaries of safety
p.000156: and effectiveness shall be sent in writing to the Freedom of Information Staff’s ad- dress listed on the Agency’s
p.000156: Web site at http:// .fda.gov.
p.000156: (e) FDA will issue an order denying approval of a PMA after an approvable or not approvable letter has
p.000156: been sent and the applicant:
...

p.000157: (d) Permanent ithdra al of approval of the PMA. If FDA issues an order tem- porarily suspending approval of a
p.000157: PMA, the agency shall proceed expeditiously, but within 60 days, to hold a hearing on whether to permanently
p.000157: withdraw ap- proval of the PMA in accordance with section 515(e)(1) of the act and the pro- cedures set out in §
p.000157: 814.46.
p.000157: [61 FR 15190, Apr. 5, 1996]
p.000157:
p.000157: Subpart D—Administrative Review
p.000157: [Reserved]
p.000157: Subpart E—Postapproval Requirements
p.000157: § 814.80 General.
p.000157: A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that
p.000157: is in- consistent with any conditions to ap- proval specified in the PMA approval order for the device.
p.000157: § 814.82 Postapproval requirements.
p.000157: (a) FDA may impose postapproval re- quirements in a PMA approval order or by regulation at the time of approval
p.000157: of the PMA or by regulation subse- quent to approval. Postapproval re- quirements may include as
p.000157: a condition to approval of the device:
p.000157: (1) Restriction of the sale, distribu- tion, or use of the device as provided by section 515(d)(1)(B)(ii) or
p.000157: 520(e) of the act.
p.000157: (2) Continuing evaluation and peri- odic reporting on the safety, effective- ness, and reliability of
p.000157: the device for its intended use. FDA will state in the PMA approval order the reason or pur- pose for
p.000157: such requirement and the number of patients to be evaluated and the reports required to be submitted.
p.000158: 158
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Food and Drug Administration, HHS § 814.84
p.000158:
p.000158:
p.000158: (3) Prominent display in the labeling of a device and in the advertising of any restricted device of
p.000158: warnings, haz- ards, or precautions important for the device’s safe and effective use, includ- ing patient
p.000158: information, e.g., informa- tion provided to the patient on alter- native modes of therapy and on risks
p.000158: and benefits associated with the use of the device.
p.000158: (4) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on
p.000158: cards given to patients if necessary to protect the public health.
p.000158: (5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace
p.000158: patients if such information is necessary to pro- tect the public health. Under section 519(a)(4) of the
p.000158: act, FDA will require that the identity of any patient be dis- closed in records maintained under this paragraph
p.000158: only to the extent required for the medical welfare of the indi- vidual, to determine the safety
p.000158: or ef- fectiveness of the device, or to verify a record, report, or information sub- mitted to the agency.
p.000158: (6) Maintenance of records for speci-
p.000158: fied periods of time and organization and indexing of records into identifi- able files to enable FDA to
p.000158: determine whether there is reasonable assurance of the continued safety and effective- ness of the device.
...

p.000159: benefit patients in the treat- ment or diagnosis of diseases or condi- tions that affect or are manifested
p.000159: in fewer than 4,000 individuals in the United States per year. This subpart provides procedures for
p.000159: obtaining:
p.000159: (1) HUD designation of a medical de- vice; and
p.000159: (2) Marketing approval for the HUD notwithstanding the absence of reason- able assurance of effectiveness
p.000159: that would otherwise be required under sec- tions 514 and 515 of the act.
p.000159: (c) Section 515A of the act is intended to ensure the submission of readily available information concerning:
p.000159: (1) Any pediatric subpopulations (neonates, infants, children, adoles- cents) that suffer from
p.000159: the disease or condition that the device is intended to treat, diagnose, or cure; and
p.000159: (2) The number of affected pediatric patients.
p.000159: (d) Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any
p.000159: non-HUD use shall submit a PMA as re- quired under § 814.20, or a premarket notification as required under
p.000159: part 807 of this chapter.
p.000159: (e) Obtaining marketing approval for a HUD involves two steps:
p.000159: (1) Obtaining designation of the de- vice as a HUD from FDA’s Office of Or- phan Products Development, and
p.000159: (2) Submitting an HDE to the Office of Device Evaluation (ODE), Center for Devices and Radiological
p.000159: Health (CDRH), the Center for Biologics Eval- uation and Research (CBER), or the Center for Drug
p.000159: Evaluation and Re- search (CDER), as applicable.
p.000159: (f) A person granted an exemption under section 520(m) of the act shall
p.000159: 21 CFR Ch. I (4–1–15 Edition)
p.000159: submit periodic reports as described in
p.000159: § 814.126(b).
p.000159: (g) FDA may suspend or withdraw ap- proval of an HDE after providing notice and an opportunity for an
p.000159: informal hearing.
p.000159: [61 FR 33244, June 26, 1996, as amended at 63
p.000159: FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25,
p.000159: 2008; 79 FR 1740, Jan. 10, 2014]
p.000159: § 814.102 Designation of HUD status.
p.000159: (a) Request for designation. Prior to submitting an HDE application, the ap- plicant shall submit a request for
p.000159: HUD designation to FDA’s Office of Orphan Products Development. The request shall contain the following:
p.000159: (1) A statement that the applicant re- quests HUD designation for a rare dis- ease or condition or a valid subset
p.000159: of a disease or condition which shall be identified with specificity;
p.000159: (2) The name and address of the ap- plicant, the name of the applicant’s primary contact person and/or
p.000159: resident agent, including title, address, and telephone number;
p.000159: (3) A description of the rare disease or condition for which the device is to be used, the proposed
p.000159: indication or in- dications for use of the device, and the reasons why such therapy is needed. If the device is
p.000159: proposed for an indication that represents a subset of a common disease or condition, a demonstration that
p.000159: the subset is medically plausible should be included;
p.000159: (4) A description of the device and a
p.000159: discussion of the scientific rationale for the use of the device for the rare disease or condition; and
p.000159: (5) Documentation, with appended authoritative references, to dem- onstrate that the device is
p.000159: designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 people
p.000159: in the United States per year. If the device is for diagnostic purposes, the documentation must demonstrate
p.000159: that fewer than 4,000 pa- tients per year would be subjected to diagnosis by the device in the United
p.000159: States. Authoritative references in- clude literature citations in specialized medical journals,
p.000159: textbooks, special- ized medical society proceedings, or governmental statistics publications. When no
p.000159: such studies or literature ci- tations exist, the applicant may be
p.000160: 160
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Food and Drug Administration, HHS § 814.104
p.000160:
p.000160:
p.000160: able to demonstrate the prevalence of the disease or condition in the United States by providing
p.000160: credible conclu- sions from appropriate research or sur- veys.
p.000160: (b) FDA action. Within 45 days of re- ceipt of a request for HUD designation, FDA will take one of the
p.000160: following ac- tions:
p.000160: (1) Approve the request and notify the applicant that the device has been designated as a HUD based
p.000160: on the in- formation submitted;
p.000160: (2) Return the request to the appli- cant pending further review upon sub- mission of additional
p.000160: information. This action will ensue if the request is in- complete because it does not on its face contain all
p.000160: of the information required under § 814.102(a). Upon receipt of this additional information, the review pe-
p.000160: riod may be extended up to 45 days; or
p.000160: (3) Disapprove the request for HUD designation based on a substantive re- view of the information
p.000160: submitted. FDA may disapprove a request for HUD designation if:
p.000160: (i) There is insufficient evidence to support the estimate that the disease or condition for which the device
p.000160: is de- signed to treat or diagnose affects or is manifested in fewer than 4,000 people in the United States per year;
p.000160: (ii) FDA determines that, for a diag- nostic device, 4,000 or more patients in the United States would
p.000160: be subjected to diagnosis using the device per year; or
p.000160: (iii) FDA determines that the patient population defined in the request is not a medically plausible subset of a larger
p.000160: population.
p.000160: (c) Revocation of designation. FDA may revoke a HUD designation if the agency finds that:
p.000160: (1) The request for designation con- tained an untrue statement of material fact or omitted material
p.000160: information; or
p.000160: (2) Based on the evidence available, the device is not eligible for HUD des- ignation.
p.000160: (d) Submission. The applicant shall submit two copies of a completed, dated, and signed request
p.000160: for HUD des- ignation to: Office of Orphan Products Development (HF–35), Food and Drug Administration,
p.000160: 5600 Fishers Lane, Rockville, MD 20857.
p.000160:
p.000160: § 814.104 Original applications.
p.000160: (a) United States applicant or represent- ative. The applicant or an authorized representative shall sign the
p.000160: HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be
p.000160: countersigned by an authorized representative resid- ing or maintaining a place of business in the United
p.000160: States and shall identify the representative’s name and address.
p.000160: (b) Contents. Unless the applicant jus- tifies an omission in accordance with paragraph (d) of this section,
p.000160: an HDE shall include:
p.000160: (1) A copy of or reference to the de- termination made by FDA’s Office of Orphan Products Development
p.000160: (in ac- cordance with § 814.102) that the device qualifies as a HUD;
p.000160: (2) An explanation of why the device would not be available unless an HDE were granted and a statement
p.000160: that no comparable device (other than another HUD approved under this subpart or a device under an approved
p.000160: IDE) is avail- able to treat or diagnose the disease or condition. The application also shall contain a
p.000160: discussion of the risks and benefits of currently available devices or alternative forms of treatment in
p.000160: the United States;
p.000160: (3) An explanation of why the prob- able benefit to health from the use of the device outweighs the risk
p.000160: of injury or illness from its use, taking into ac- count the probable risks and benefits of currently
...

p.000161: fabrication, and distribution. If the amount charged is
p.000161: $250 or less, the requirement for a re- port by an independent certified public accountant or an attestation
p.000161: by a re- sponsible individual of the organiza- tion is waived; and
p.000161: (6) Information concerning pediatric uses of the device, as required by
p.000161: § 814.20(b)(13).
p.000161: (c) Omission of information. If the ap- plicant believes that certain informa- tion required under
p.000161: paragraph (b) of this section is not applicable to the de- vice that is the subject of the HDE, and omits any
p.000161: such information from its HDE, the applicant shall submit a statement that identifies and justifies
p.000161: the omission. The statement shall be submitted as a separate section in the HDE and identified in the table
p.000161: of con- tents. If the justification for the omis- sion is not accepted by the agency, FDA will so
p.000161: notify the applicant.
p.000161: (d) Address for submissions and cor-
p.000161: respondence. Copies of all original HDEs amendments and supplements, as well as any correspondence relating to
p.000161: an HDE, must be sent or delivered to the following:
p.000161: (1) For devices regulated by the Cen- ter for Devices and Radiological Health, send to Document
p.000161: Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993–0002.
p.000161: 21 CFR Ch. I (4–1–15 Edition)
p.000161: (2) For devices regulated by the Cen- ter for Biologics Evaluation and Re- search, send this
p.000161: information to the Document Control Center (HFM–99), Center for Biologics Evaluation and Research,
p.000161: Food and Drug Administra- tion, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448.
p.000161: (3) For devices regulated by the Cen-
p.000161: ter for Drug Evaluation and Research, send this information to the Central Document Control Room,
p.000161: Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd.,
p.000161: Beltsville, MD 20705– 1266.
p.000161: [61 FR 33244, June 26, 1996, as amended at 63
p.000161: FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25,
p.000161: 2008; 75 FR 20915, Apr. 22, 2010; 79 FR 1740,
p.000161: Jan. 10, 2014]
p.000161:
p.000161: § 814.106 HDE amendments and resub- mitted HDE’s.
p.000161: An HDE or HDE supplement may be amended or resubmitted upon an appli- cant’s own initiative, or at the request of
p.000161: FDA, for the same reasons and in the same manner as prescribed for PMA’s in § 814.37, except that the
p.000161: time- frames set forth in § 814.37(c)(1) and (d) do not apply. If FDA requests an HDE applicant to
p.000161: submit an HDE amend- ment, and a written response to FDA’s request is not received within 75 days of
p.000161: the date of the request, FDA will consider the pending HDE or HDE sup- plement to be withdrawn
p.000161: voluntarily by the applicant. Furthermore, if the HDE applicant, on its own initiative or at FDA’s request,
p.000161: submits a major amendment as described in
p.000161: § 814.37(c)(1), the review period may be
p.000161: extended up to 75 days.
p.000161: [63 FR 59220, Nov. 3, 1998]
p.000161: § 814.108 Supplemental applications.
p.000161: After FDA approval of an original HDE, an applicant shall submit supple- ments in accordance with the
p.000161: require- ments for PMA’s under § 814.39, except that a request for a new indication for use of a HUD
p.000161: shall comply with re- quirements set forth in § 814.110. The timeframes for review of, and FDA ac- tion
p.000161: on, an HDE supplement are the same as those provided in § 814.114 for an HDE.
p.000161: [63 FR 59220, Nov. 3, 1998]
p.000162: 162
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162: Food and Drug Administration, HHS § 814.116
p.000162:
p.000162:
p.000162: § 814.110 New indications for use.
p.000162: (a) An applicant seeking a new indi- cation for use of a HUD approved under this subpart H shall obtain a
p.000162: new des- ignation of HUD status in accordance with § 814.102 and shall submit an origi- nal HDE in accordance
p.000162: with § 814.104.
p.000162: (b) An application for a new indica- tion for use made under § 814.104 may incorporate by reference any
p.000162: informa- tion or data previously submitted to the agency under an HDE.
p.000162: § 814.112 Filing an HDE.
p.000162: (a) The filing of an HDE means that FDA has made a threshold determina- tion that the application is
p.000162: sufficiently complete to permit substantive review. Within 30 days from the date an HDE is received by FDA, the
p.000162: agency will no- tify the applicant whether the applica- tion has been filed. FDA may refuse to file an HDE if
p.000162: any of the following ap- plies:
p.000162: (1) The application is incomplete be- cause it does not on its face contain all the information
p.000162: required under
p.000162: § 814.104(b);
p.000162: (2) FDA determines that there is a comparable device available (other than another HUD approved
p.000162: under this subpart or a device under an approved IDE) to treat or diagnose the disease or condition for
p.000162: which approval of the HUD is being sought; or
p.000162: (3) The application contains an un- true statement of material fact or omits material information.
p.000162: (4) The HDE is not accompanied by a statement of either certification or dis- closure, or both, as required by
p.000162: part 54 of this chapter.
p.000162: (b) The provisions contained in
...

p.000163: (1) There is a lack of a showing of
p.000163: reasonable assurance that the device is safe under the conditions of use pre- scribed, recommended, or
p.000163: suggested in the labeling thereof;
p.000163: (2) The device is ineffective under the conditions of use prescribed, rec- ommended, or suggested in the
p.000163: labeling thereof;
p.000163: (3) The applicant has not dem- onstrated that there is a reasonable basis from which to
p.000163: conclude that the probable benefit to health from the use of the device outweighs the risk of in- jury or
p.000163: illness, taking into account the probable risks and benefits of currently available devices or alternative forms of
p.000163: treatment;
p.000163: (4) The application or a report sub-
p.000163: mitted by or on behalf of the applicant contains an untrue statement of mate- rial fact, or omits material
p.000163: informa- tion;
p.000163: (5) The device’s labeling does not comply with the requirements in part 801 or part 809 of this chapter;
p.000163: (6) A nonclinical laboratory study that is described in the HDE and that is essential to show that
p.000163: the device is safe for use under the conditions pre- scribed, recommended, or suggested in its proposed
p.000163: labeling, was not con- ducted in compliance with the good laboratory practice regulations in part
p.000163: 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the
p.000163: practices
p.000164: 164
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: Food and Drug Administration, HHS § 814.124
p.000164:
p.000164:
p.000164: used in conducting the study and the good laboratory practice regulations do not support the validity of the
p.000164: study;
p.000164: (7) Any clinical investigation involv- ing human subjects described in the HDE, subject to the
p.000164: institutional re- view board regulations in part 56 of this chapter or the informed consent
p.000164: regulations in part 50 of this chapter, was not conducted in compliance with those regulations such that
p.000164: the rights or safety of human subjects were not adequately protected;
p.000164: (8) The applicant does not permit an authorized FDA employee an oppor- tunity to inspect at a
p.000164: reasonable time and in a reasonable manner the facili- ties and controls, and to have access to and to copy
p.000164: and verify all records per- tinent to the application; or
p.000164: (9) The device’s HUD designation should be revoked in accordance with
p.000164: § 814.102(c).
p.000164: (b) If FDA issues an order denying approval of an application, the agency will comply with the same
p.000164: notice and disclosure provisions required for PMA’s under § 814.45(b) and (d), as ap- plicable.
p.000164: (c) FDA will issue an order denying approval of an HDE after an approvable or not approvable letter has been
p.000164: sent and the applicant:
p.000164: (1) Submits a requested amendment but any ground for denying approval of the application under § 814.118(a)
p.000164: still applies;
p.000164: (2) Notifies FDA in writing that the requested amendment will not be sub- mitted; or
...

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Searching for indicator illness:

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p.000160: 5600 Fishers Lane, Rockville, MD 20857.
p.000160:
p.000160: § 814.104 Original applications.
p.000160: (a) United States applicant or represent- ative. The applicant or an authorized representative shall sign the
p.000160: HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be
p.000160: countersigned by an authorized representative resid- ing or maintaining a place of business in the United
p.000160: States and shall identify the representative’s name and address.
p.000160: (b) Contents. Unless the applicant jus- tifies an omission in accordance with paragraph (d) of this section,
p.000160: an HDE shall include:
p.000160: (1) A copy of or reference to the de- termination made by FDA’s Office of Orphan Products Development
p.000160: (in ac- cordance with § 814.102) that the device qualifies as a HUD;
p.000160: (2) An explanation of why the device would not be available unless an HDE were granted and a statement
p.000160: that no comparable device (other than another HUD approved under this subpart or a device under an approved
p.000160: IDE) is avail- able to treat or diagnose the disease or condition. The application also shall contain a
p.000160: discussion of the risks and benefits of currently available devices or alternative forms of treatment in
p.000160: the United States;
p.000160: (3) An explanation of why the prob- able benefit to health from the use of the device outweighs the risk
p.000160: of injury or illness from its use, taking into ac- count the probable risks and benefits of currently
p.000160: available devices or alter- native forms of treatment. Such expla- nation shall include a description, ex-
p.000160: planation, or theory of the underlying disease process or condition, and known or postulated
p.000160: mechanism(s) of action of the device in relation to the disease process or condition;
p.000160: (4) All of the information required to be submitted under § 814.20(b), except that:
p.000160: (i) In lieu of the summaries, conclu- sions, and results from clinical inves- tigations
p.000160: required under
p.000160: §§ 814.20(b)(3)(v)(B), (b)(3)(vi), and
p.000160: (b)(6)(ii), the applicant shall include the summaries, conclusions, and re- sults of all clinical
p.000160: experience or inves- tigations (whether adverse or sup- portive) reasonably obtainable by the
p.000161: 161
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: § 814.106
p.000161: applicant that are relevant to an as- sessment of the risks and probable ben- efits of the device; and
p.000161: (ii) In addition to the proposed label- ing requirement set forth in
p.000161: § 814.20(b)(10), the labeling shall bear the following statement: Humanitarian Device. Authorized by Federal
p.000161: law for use in the [treatment or diagnosis] of [specify disease or condition]. The ef- fectiveness of
p.000161: this device for this use has not been demonstrated;
p.000161: (5) The amount to be charged for the device and, if the amount is more than
...

p.000163: (2) The applicant fails to respond in writing to an approvable or not approv- able letter within 75 days after
p.000163: the date FDA issues such letter; or
p.000163: 21 CFR Ch. I (4–1–15 Edition)
p.000163: (3) The applicant submits a written notice to FDA that the HDE has been withdrawn.
p.000163: [61 FR 33244, June 26, 1996, as amended at 63
p.000163: FR 59221, Nov. 3, 1998; 79 FR 1741, Jan. 10,
p.000163: 2014]
p.000163:
p.000163: § 814.118 Denial of approval or with- drawal of approval of an HDE.
p.000163: (a) FDA may deny approval or with- draw approval of an application if the applicant fails to meet
p.000163: the require- ments of section 520(m) of the act or of this part, or of any condition of ap- proval imposed
p.000163: by an IRB or by FDA, or any postapproval requirements im- posed under § 814.126. In addition, FDA may
p.000163: deny approval or withdraw ap- proval of an application if, upon the basis of the information
p.000163: submitted in the HDE or any other information be- fore the agency, FDA determines that:
p.000163: (1) There is a lack of a showing of
p.000163: reasonable assurance that the device is safe under the conditions of use pre- scribed, recommended, or
p.000163: suggested in the labeling thereof;
p.000163: (2) The device is ineffective under the conditions of use prescribed, rec- ommended, or suggested in the
p.000163: labeling thereof;
p.000163: (3) The applicant has not dem- onstrated that there is a reasonable basis from which to
p.000163: conclude that the probable benefit to health from the use of the device outweighs the risk of in- jury or
p.000163: illness, taking into account the probable risks and benefits of currently available devices or alternative forms of
p.000163: treatment;
p.000163: (4) The application or a report sub-
p.000163: mitted by or on behalf of the applicant contains an untrue statement of mate- rial fact, or omits material
p.000163: informa- tion;
p.000163: (5) The device’s labeling does not comply with the requirements in part 801 or part 809 of this chapter;
p.000163: (6) A nonclinical laboratory study that is described in the HDE and that is essential to show that
p.000163: the device is safe for use under the conditions pre- scribed, recommended, or suggested in its proposed
p.000163: labeling, was not con- ducted in compliance with the good laboratory practice regulations in part
p.000163: 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the
p.000163: practices
p.000164: 164
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: Food and Drug Administration, HHS § 814.124
p.000164:
p.000164:
p.000164: used in conducting the study and the good laboratory practice regulations do not support the validity of the
p.000164: study;
p.000164: (7) Any clinical investigation involv- ing human subjects described in the HDE, subject to the
p.000164: institutional re- view board regulations in part 56 of this chapter or the informed consent
p.000164: regulations in part 50 of this chapter, was not conducted in compliance with those regulations such that
p.000164: the rights or safety of human subjects were not adequately protected;
...

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p.000155: reconsideration under
p.000155: § 10.33; or
p.000155: (3) Withdraw the PMA.
p.000155: (g) FDA will consider a PMA to have been withdrawn voluntarily if:
p.000155: (1) The applicant fails to respond in writing to a written request for an amendment within 180
p.000155: days after the date FDA issues such request;
p.000155: (2) The applicant fails to respond in writing to an approvable or not approv- able letter within 180 days
p.000155: after the date FDA issues such letter; or
p.000155: (3) The applicant submits a written notice to FDA that the PMA has been withdrawn.
p.000155: [51 FR 26364, July 22, 1986, as amended at 57
p.000155: FR 58403, Dec. 10, 1992; 63 FR 4572, Jan. 30,
p.000155: 1998; 79 FR 1740, Jan. 10, 2014]
p.000155: § 814.45 Denial of approval of a PMA.
p.000155: (a) FDA may issue an order denying approval of a PMA if the applicant fails
p.000155: 21 CFR Ch. I (4–1–15 Edition)
p.000155: to follow the requirements of this part or if, upon the basis of the information submitted in the PMA or any
p.000155: other in- formation before the agency, FDA de- termines that any of the grounds for denying approval of a
p.000155: PMA specified in section 515(d)(2) (A)–(E) of the act ap- plies. In addition, FDA may deny ap- proval of
p.000155: a PMA for any of the fol- lowing reasons:
p.000155: (1) The PMA contains a false state- ment of material fact;
p.000155: (2) The device’s proposed labeling does not comply with the requirements in part 801 or part 809;
p.000155: (3) The applicant does not permit an authorized FDA employee an oppor- tunity to inspect at a
p.000155: reasonable time and in a reasonable manner the facili- ties, controls, and to have access to and to copy
p.000155: and verify all records per- tinent to the application;
p.000155: (4) A nonclinical laboratory study that is described in the PMA and that is essential to show that
p.000155: the device is safe for use under the conditions pre- scribed, recommended, or suggested in its proposed
p.000155: labeling, was not con- ducted in compliance with the good laboratory practice regulations in part
p.000155: 58 and no reason for the noncompliance is provided or, if it is, the differences between the practices
p.000155: used in con- ducting the study and the good labora- tory practice regulations do not sup- port the validity of
p.000155: the study; or
p.000155: (5) Any clinical investigation involv- ing human subjects described in the PMA, subject to the
p.000155: institutional re- view board regulations in part 56 or in- formed consent regulations in part 50, was not
p.000155: conducted in compliance with those regulations such that the rights or safety of human subjects were not
p.000155: adequately protected.
p.000155: (b) FDA will issue any order denying approval of the PMA in accordance with § 814.17. The order
p.000155: will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under
p.000155: section 515(d)(2) of the act and the regulations under this part, and, where practical, will identify
p.000155: measures required to place the PMA in approvable form. The order will include a notice of an opportunity to
p.000155: request review under section 515(d)(4) of the act.
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
...

p.000158: and benefits associated with the use of the device.
p.000158: (4) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on
p.000158: cards given to patients if necessary to protect the public health.
p.000158: (5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace
p.000158: patients if such information is necessary to pro- tect the public health. Under section 519(a)(4) of the
p.000158: act, FDA will require that the identity of any patient be dis- closed in records maintained under this paragraph
p.000158: only to the extent required for the medical welfare of the indi- vidual, to determine the safety
p.000158: or ef- fectiveness of the device, or to verify a record, report, or information sub- mitted to the agency.
p.000158: (6) Maintenance of records for speci-
p.000158: fied periods of time and organization and indexing of records into identifi- able files to enable FDA to
p.000158: determine whether there is reasonable assurance of the continued safety and effective- ness of the device.
p.000158: (7) Submission to FDA at intervals specified in the approval order of peri- odic reports containing
p.000158: the informa- tion required by § 814.84(b).
p.000158: (8) Batch testing of the device.
p.000158: (9) Such other requirements as FDA determines are necessary to provide reasonable assurance, or continued
p.000158: rea- sonable assurance, of the safety and ef- fectiveness of the device.
p.000158: (b) An applicant shall grant to FDA access to any records and reports re- quired under the provisions
p.000158: of this part, and shall permit authorized FDA employees to copy and verify such records and reports
p.000158: and to inspect at a reasonable time and in a reasonable manner all manufacturing facilities to verify
p.000158: that the device is being manu- factured, stored, labeled, and shipped under approved conditions.
p.000158: (c) Failure to comply with any post- approval requirement constitutes a
p.000158:
p.000158: ground for withdrawal of approval of a PMA.
p.000158: (Approved by the Office of Management and Budget under control number 0910–0231)
p.000158: [51 FR 26364, July 22, 1986, as amended at 51
p.000158: FR 43344, Dec. 2, 1986]
p.000158:
p.000158: § 814.84 Reports.
p.000158: (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other
p.000158: require- ments applicable to the device by other regulations in this subchapter or by order approving the
p.000158: device.
p.000158: (b) Unless FDA specifies otherwise, any periodic report shall:
p.000158: (1) Identify changes described in
p.000158: § 814.39(a) and changes required to be reported to FDA under § 814.39(b).
p.000158: (2) Contain a summary and bibliog- raphy of the following information not previously submitted as part
p.000158: of the PMA:
p.000158: (i) Unpublished reports of data from any clinical investigations or nonclin- ical laboratory studies
p.000158: involving the device or related devices and known to or that reasonably should be known to the applicant.
p.000158: (ii) Reports in the scientific lit- erature concerning the device and known to or that
...

p.000163: informa- tion;
p.000163: (5) The device’s labeling does not comply with the requirements in part 801 or part 809 of this chapter;
p.000163: (6) A nonclinical laboratory study that is described in the HDE and that is essential to show that
p.000163: the device is safe for use under the conditions pre- scribed, recommended, or suggested in its proposed
p.000163: labeling, was not con- ducted in compliance with the good laboratory practice regulations in part
p.000163: 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the
p.000163: practices
p.000164: 164
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: Food and Drug Administration, HHS § 814.124
p.000164:
p.000164:
p.000164: used in conducting the study and the good laboratory practice regulations do not support the validity of the
p.000164: study;
p.000164: (7) Any clinical investigation involv- ing human subjects described in the HDE, subject to the
p.000164: institutional re- view board regulations in part 56 of this chapter or the informed consent
p.000164: regulations in part 50 of this chapter, was not conducted in compliance with those regulations such that
p.000164: the rights or safety of human subjects were not adequately protected;
p.000164: (8) The applicant does not permit an authorized FDA employee an oppor- tunity to inspect at a
p.000164: reasonable time and in a reasonable manner the facili- ties and controls, and to have access to and to copy
p.000164: and verify all records per- tinent to the application; or
p.000164: (9) The device’s HUD designation should be revoked in accordance with
p.000164: § 814.102(c).
p.000164: (b) If FDA issues an order denying approval of an application, the agency will comply with the same
p.000164: notice and disclosure provisions required for PMA’s under § 814.45(b) and (d), as ap- plicable.
p.000164: (c) FDA will issue an order denying approval of an HDE after an approvable or not approvable letter has been
p.000164: sent and the applicant:
p.000164: (1) Submits a requested amendment but any ground for denying approval of the application under § 814.118(a)
p.000164: still applies;
p.000164: (2) Notifies FDA in writing that the requested amendment will not be sub- mitted; or
p.000164: (3) Petitions for review under section 515(d)(3) of the act by filing a petition in the form of a petition for
p.000164: reconsider- ation under § 10.33 of this chapter.
p.000164: (d) Before issuing an order with- drawing approval of an HDE, FDA will provide the applicant with
p.000164: notice and an opportunity for a hearing as re- quired for PMA’s under § 814.46(c) and (d), and will
p.000164: provide the public with no- tice in accordance with § 814.46(e), as applicable.
p.000164: [61 FR 33244, June 26, 1996, as amended at 63
p.000164: FR 59221, Nov. 3, 1998]
p.000164:
p.000164: § 814.120 Temporary suspension of ap- proval of an HDE.
p.000164: An HDE or HDE supplement may be temporarily suspended for the same
p.000164:
p.000164: reasons and in the same manner as pre- scribed for PMA’s in § 814.47.
p.000164: [63 FR 59221, Nov. 3, 1998]
p.000164:
p.000164: § 814.122 Confidentiality of data and information.
...

Social / Access to information

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Social / Age

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p.000143: defined in
p.000143: § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a
p.000143: device.
p.000143: (q) Unique device identifier (UDI)
p.000143: means an identifier that adequately
p.000144: 144
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: Food and Drug Administration, HHS § 814.9
p.000144:
p.000144:
p.000144: identifies a device through its distribu- tion and use by meeting the require- ments of § 830.20 of this
p.000144: chapter. A unique device identifier is composed of:
p.000144: (1) A device identifier—a mandatory, fixed portion of a UDI that identifies the specific version or
p.000144: model of a de- vice and the labeler of that device; and
p.000144: (2) A production identifier—a condi- tional, variable portion of a UDI that identifies one or more of
p.000144: the following when included on the label of the de- vice:
p.000144: (i) The lot or batch within which a device was manufactured;
p.000144: (ii) The serial number of a specific device;
p.000144: (iii) The expiration date of a specific device;
p.000144: (iv) The date a specific device was manufactured.
p.000144: (v) For an HCT/P regulated as a de- vice, the distinct identification code required by § 1271.290(c) of
p.000144: this chapter.
p.000144: (r) Universal product code (UPC) means the product identifier used to identify an item sold at
p.000144: retail in the United States.
p.000144: (s) Pediatric patients means patients who are 21 years of age or younger (that is, from birth
p.000144: through the twen- ty-first year of life, up to but not in- cluding the twenty-second birthday) at the time of
p.000144: the diagnosis or treatment.
p.000144: (t) Readily available means available in the public domain through com- monly used public resources
p.000144: for con- ducting biomedical, regulatory, and medical product research.
p.000144: [51 FR 26364, July 22, 1986, as amended at 61
p.000144: FR 15190, Apr. 5, 1996; 61 FR 33244, June 26,
p.000144: 1996; 73 FR 49610, Aug. 22, 2008; 78 FR 55821,
p.000144: Sept. 24, 2013; 79 FR 1740, Jan. 10, 2014]
p.000144:
p.000144: § 814.9 Confidentiality of data and in- formation in a premarket approval application (PMA) file.
p.000144: (a) A ‘‘PMA file’’ includes all data and information submitted with or in- corporated by reference in
p.000144: the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under
p.000144: § 814.82, any master file, or any other related submission. Any record in the PMA file will be available
p.000144: for public disclosure in accordance with the pro- visions of this section and part 20. The
p.000144: confidentiality of information in a
p.000144:
p.000144: color additive petition submitted as part of a PMA is governed by § 71.15.
p.000144: (b) The existence of a PMA file may not be disclosed by FDA before an ap- proval order is issued to
p.000144: the applicant unless it previously has been publicly disclosed or acknowledged.
p.000144: (c) If the existence of a PMA file has not been publicly disclosed or acknowl- edged, data or information in
p.000144: the PMA file are not available for public disclo- sure.
...

p.000158: (ii) Reports in the scientific lit- erature concerning the device and known to or that
p.000158: reasonably should be known to the applicant. If, after re- viewing the summary and bibliog- raphy,
p.000158: FDA concludes that the agency needs a copy of the unpublished or pub- lished reports, FDA will notify the ap-
p.000158: plicant that copies of such reports shall be submitted.
p.000158: (3) Identify changes made pursuant to an exception or alternative granted under § 801.128 or § 809.11 of this
p.000158: chapter.
p.000158: (4) Identify each device identifier currently in use for the device, and each device identifier
p.000158: for the device that has been discontinued since the previous periodic report. It is not nec- essary
p.000158: to identify any device identifier discontinued prior to December 23, 2013.
p.000158: [51 FR 26364, July 22, 1986, as amended at 51
p.000158: FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002;
p.000158: 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept.
p.000158: 24, 2013]
p.000158:
p.000158: Subparts F–G [Reserved]
p.000159: 159
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: § 814.100
p.000159: Subpart H—Humanitarian Use Devices
p.000159: SOURCE: 61 FR 33244, June 26, 1996, unless
p.000159: otherwise noted.
p.000159: § 814.100 Purpose and scope.
p.000159: (a) This subpart H implements sec- tions 515A and 520(m) of the act.
p.000159: (b) The purpose of section 520(m) is, to the extent consistent with the pro- tection of the public
p.000159: health and safety and with ethical standards, to encour- age the discovery and use of devices in- tended to
p.000159: benefit patients in the treat- ment or diagnosis of diseases or condi- tions that affect or are manifested
p.000159: in fewer than 4,000 individuals in the United States per year. This subpart provides procedures for
p.000159: obtaining:
p.000159: (1) HUD designation of a medical de- vice; and
p.000159: (2) Marketing approval for the HUD notwithstanding the absence of reason- able assurance of effectiveness
p.000159: that would otherwise be required under sec- tions 514 and 515 of the act.
p.000159: (c) Section 515A of the act is intended to ensure the submission of readily available information concerning:
p.000159: (1) Any pediatric subpopulations (neonates, infants, children, adoles- cents) that suffer from
p.000159: the disease or condition that the device is intended to treat, diagnose, or cure; and
p.000159: (2) The number of affected pediatric patients.
p.000159: (d) Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any
p.000159: non-HUD use shall submit a PMA as re- quired under § 814.20, or a premarket notification as required under
p.000159: part 807 of this chapter.
p.000159: (e) Obtaining marketing approval for a HUD involves two steps:
p.000159: (1) Obtaining designation of the de- vice as a HUD from FDA’s Office of Or- phan Products Development, and
p.000159: (2) Submitting an HDE to the Office of Device Evaluation (ODE), Center for Devices and Radiological
p.000159: Health (CDRH), the Center for Biologics Eval- uation and Research (CBER), or the Center for Drug
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p.000158: to identify any device identifier discontinued prior to December 23, 2013.
p.000158: [51 FR 26364, July 22, 1986, as amended at 51
p.000158: FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002;
p.000158: 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept.
p.000158: 24, 2013]
p.000158:
p.000158: Subparts F–G [Reserved]
p.000159: 159
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: § 814.100
p.000159: Subpart H—Humanitarian Use Devices
p.000159: SOURCE: 61 FR 33244, June 26, 1996, unless
p.000159: otherwise noted.
p.000159: § 814.100 Purpose and scope.
p.000159: (a) This subpart H implements sec- tions 515A and 520(m) of the act.
p.000159: (b) The purpose of section 520(m) is, to the extent consistent with the pro- tection of the public
p.000159: health and safety and with ethical standards, to encour- age the discovery and use of devices in- tended to
p.000159: benefit patients in the treat- ment or diagnosis of diseases or condi- tions that affect or are manifested
p.000159: in fewer than 4,000 individuals in the United States per year. This subpart provides procedures for
p.000159: obtaining:
p.000159: (1) HUD designation of a medical de- vice; and
p.000159: (2) Marketing approval for the HUD notwithstanding the absence of reason- able assurance of effectiveness
p.000159: that would otherwise be required under sec- tions 514 and 515 of the act.
p.000159: (c) Section 515A of the act is intended to ensure the submission of readily available information concerning:
p.000159: (1) Any pediatric subpopulations (neonates, infants, children, adoles- cents) that suffer from
p.000159: the disease or condition that the device is intended to treat, diagnose, or cure; and
p.000159: (2) The number of affected pediatric patients.
p.000159: (d) Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any
p.000159: non-HUD use shall submit a PMA as re- quired under § 814.20, or a premarket notification as required under
p.000159: part 807 of this chapter.
p.000159: (e) Obtaining marketing approval for a HUD involves two steps:
p.000159: (1) Obtaining designation of the de- vice as a HUD from FDA’s Office of Or- phan Products Development, and
p.000159: (2) Submitting an HDE to the Office of Device Evaluation (ODE), Center for Devices and Radiological
p.000159: Health (CDRH), the Center for Biologics Eval- uation and Research (CBER), or the Center for Drug
p.000159: Evaluation and Re- search (CDER), as applicable.
p.000159: (f) A person granted an exemption under section 520(m) of the act shall
p.000159: 21 CFR Ch. I (4–1–15 Edition)
p.000159: submit periodic reports as described in
p.000159: § 814.126(b).
p.000159: (g) FDA may suspend or withdraw ap- proval of an HDE after providing notice and an opportunity for an
p.000159: informal hearing.
p.000159: [61 FR 33244, June 26, 1996, as amended at 63
p.000159: FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25,
p.000159: 2008; 79 FR 1740, Jan. 10, 2014]
p.000159: § 814.102 Designation of HUD status.
p.000159: (a) Request for designation. Prior to submitting an HDE application, the ap- plicant shall submit a request for
...

Social / Fetus/Neonate

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p.000148: (iii) Copies of such published reports or unpublished information in the pos- session of or reasonably
p.000148: obtainable by the applicant if an FDA advisory com- mittee or FDA requests.
p.000148: (9) One or more samples of the device and its components, if requested by FDA. If it is impractical to
p.000148: submit a requested sample of the device, the ap- plicant shall name the location at which FDA may examine
p.000148: and test one or more devices.
p.000148: (10) Copies of all proposed labeling for the device. Such labeling may in- clude, e.g., instructions
p.000148: for installation
p.000149: 149
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149: § 814.20
p.000149: and any information, literature, or ad- vertising that constitutes labeling under section 201(m) of the
p.000149: act.
p.000149: (11) An environmental assessment under § 25.20(n) prepared in the applica- ble format in § 25.40, unless
p.000149: the action qualifies for exclusion under § 25.30 or
p.000149: § 25.34. If the applicant believes that the action qualifies for exclusion, the PMA shall under §
p.000149: 25.15(a) and (d) pro- vide information that establishes to FDA’s satisfaction that the action re-
p.000149: quested is included within the excluded category and meets the criteria for the applicable exclusion.
p.000149: (12) A financial certification or dis- closure statement or both as required by part 54 of this chapter.
p.000149: (13) Information concerning uses in pe- diatric patients. The application must include the following
p.000149: information, if readily available:
p.000149: (i) A description of any pediatric sub- populations (neonates, infants, chil- dren, adolescents) that suffer
p.000149: from the disease or condition that the device is intended to treat, diagnose, or cure; and
p.000149: (ii) The number of affected pediatric patients.
p.000149: (14) Such other information as FDA may request. If necessary, FDA will ob- tain the concurrence of the appropriate
p.000149: FDA advisory committee before re- questing additional information.
p.000149: (c) Pertinent information in FDA files specifically referred to by an ap- plicant may be
p.000149: incorporated into a PMA by reference. Information in a master file or other information sub- mitted
p.000149: to FDA by a person other than the applicant will not be considered part of a PMA unless such
p.000149: reference is authorized in writing by the person who submitted the information or the master file. If
p.000149: a master file is not ref- erenced within 5 years after the date that it is submitted to FDA, FDA
p.000149: will return the master file to the person who submitted it.
p.000149: (d) If the applicant believes that cer-
p.000149: tain information required under para- graph (b) of this section to be in a PMA is not applicable to the device
p.000149: that is the subject of the PMA, and omits any such information from its PMA, the ap- plicant shall submit a
p.000149: statement that identifies the omitted information and justifies the omission. The statement
p.000149: 21 CFR Ch. I (4–1–15 Edition)
p.000149: shall be submitted as a separate sec- tion in the PMA and identified in the table of contents. If the
p.000149: justification for the omission is not accepted by the agency, FDA will so notify the appli- cant.
...

p.000158: to identify any device identifier discontinued prior to December 23, 2013.
p.000158: [51 FR 26364, July 22, 1986, as amended at 51
p.000158: FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002;
p.000158: 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept.
p.000158: 24, 2013]
p.000158:
p.000158: Subparts F–G [Reserved]
p.000159: 159
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: § 814.100
p.000159: Subpart H—Humanitarian Use Devices
p.000159: SOURCE: 61 FR 33244, June 26, 1996, unless
p.000159: otherwise noted.
p.000159: § 814.100 Purpose and scope.
p.000159: (a) This subpart H implements sec- tions 515A and 520(m) of the act.
p.000159: (b) The purpose of section 520(m) is, to the extent consistent with the pro- tection of the public
p.000159: health and safety and with ethical standards, to encour- age the discovery and use of devices in- tended to
p.000159: benefit patients in the treat- ment or diagnosis of diseases or condi- tions that affect or are manifested
p.000159: in fewer than 4,000 individuals in the United States per year. This subpart provides procedures for
p.000159: obtaining:
p.000159: (1) HUD designation of a medical de- vice; and
p.000159: (2) Marketing approval for the HUD notwithstanding the absence of reason- able assurance of effectiveness
p.000159: that would otherwise be required under sec- tions 514 and 515 of the act.
p.000159: (c) Section 515A of the act is intended to ensure the submission of readily available information concerning:
p.000159: (1) Any pediatric subpopulations (neonates, infants, children, adoles- cents) that suffer from
p.000159: the disease or condition that the device is intended to treat, diagnose, or cure; and
p.000159: (2) The number of affected pediatric patients.
p.000159: (d) Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any
p.000159: non-HUD use shall submit a PMA as re- quired under § 814.20, or a premarket notification as required under
p.000159: part 807 of this chapter.
p.000159: (e) Obtaining marketing approval for a HUD involves two steps:
p.000159: (1) Obtaining designation of the de- vice as a HUD from FDA’s Office of Or- phan Products Development, and
p.000159: (2) Submitting an HDE to the Office of Device Evaluation (ODE), Center for Devices and Radiological
p.000159: Health (CDRH), the Center for Biologics Eval- uation and Research (CBER), or the Center for Drug
p.000159: Evaluation and Re- search (CDER), as applicable.
p.000159: (f) A person granted an exemption under section 520(m) of the act shall
p.000159: 21 CFR Ch. I (4–1–15 Edition)
p.000159: submit periodic reports as described in
p.000159: § 814.126(b).
p.000159: (g) FDA may suspend or withdraw ap- proval of an HDE after providing notice and an opportunity for an
p.000159: informal hearing.
p.000159: [61 FR 33244, June 26, 1996, as amended at 63
p.000159: FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25,
p.000159: 2008; 79 FR 1740, Jan. 10, 2014]
p.000159: § 814.102 Designation of HUD status.
p.000159: (a) Request for designation. Prior to submitting an HDE application, the ap- plicant shall submit a request for
...

Social / Incarcerated

Searching for indicator restricted:

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p.000157: withdraw ap- proval of the PMA in accordance with section 515(e)(1) of the act and the pro- cedures set out in §
p.000157: 814.46.
p.000157: [61 FR 15190, Apr. 5, 1996]
p.000157:
p.000157: Subpart D—Administrative Review
p.000157: [Reserved]
p.000157: Subpart E—Postapproval Requirements
p.000157: § 814.80 General.
p.000157: A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that
p.000157: is in- consistent with any conditions to ap- proval specified in the PMA approval order for the device.
p.000157: § 814.82 Postapproval requirements.
p.000157: (a) FDA may impose postapproval re- quirements in a PMA approval order or by regulation at the time of approval
p.000157: of the PMA or by regulation subse- quent to approval. Postapproval re- quirements may include as
p.000157: a condition to approval of the device:
p.000157: (1) Restriction of the sale, distribu- tion, or use of the device as provided by section 515(d)(1)(B)(ii) or
p.000157: 520(e) of the act.
p.000157: (2) Continuing evaluation and peri- odic reporting on the safety, effective- ness, and reliability of
p.000157: the device for its intended use. FDA will state in the PMA approval order the reason or pur- pose for
p.000157: such requirement and the number of patients to be evaluated and the reports required to be submitted.
p.000158: 158
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Food and Drug Administration, HHS § 814.84
p.000158:
p.000158:
p.000158: (3) Prominent display in the labeling of a device and in the advertising of any restricted device of
p.000158: warnings, haz- ards, or precautions important for the device’s safe and effective use, includ- ing patient
p.000158: information, e.g., informa- tion provided to the patient on alter- native modes of therapy and on risks
p.000158: and benefits associated with the use of the device.
p.000158: (4) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on
p.000158: cards given to patients if necessary to protect the public health.
p.000158: (5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace
p.000158: patients if such information is necessary to pro- tect the public health. Under section 519(a)(4) of the
p.000158: act, FDA will require that the identity of any patient be dis- closed in records maintained under this paragraph
p.000158: only to the extent required for the medical welfare of the indi- vidual, to determine the safety
p.000158: or ef- fectiveness of the device, or to verify a record, report, or information sub- mitted to the agency.
p.000158: (6) Maintenance of records for speci-
p.000158: fied periods of time and organization and indexing of records into identifi- able files to enable FDA to
p.000158: determine whether there is reasonable assurance of the continued safety and effective- ness of the device.
p.000158: (7) Submission to FDA at intervals specified in the approval order of peri- odic reports containing
p.000158: the informa- tion required by § 814.84(b).
p.000158: (8) Batch testing of the device.
...

Social / Marital Status

Searching for indicator single:

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p.000148: individual subject report forms and copies of such forms for each subject who died during a clinical investigation
p.000148: or who did not complete the investigation, results of statistical analyses of the clinical in-
p.000148: vestigations, device failures and re- placements, contraindications and pre- cautions for use of the
p.000148: device, and any other appropriate information from the clinical investigations. Any investiga- tion conducted
p.000148: under an IDE shall be identified as such. Information on clin- ical investigations involving human subjects
p.000148: shall include the following:
p.000148: (A) A statement with respect to each
p.000148: study that it either was conducted in compliance with the institutional re- view board regulations in
p.000148: part 56, or
p.000148:
p.000148: was not subject to the regulations under § 56.104 or § 56.105, and that it was conducted in compliance
p.000148: with the in- formed consent regulations in part 50; or if the study was not conducted in compliance with
p.000148: those regulations, a brief statement of the reason for the noncompliance.
p.000148: (B) A statement that each study was conducted in compliance with part 812 or part 813 concerning sponsors of
p.000148: clin- ical investigations and clinical inves- tigators, or if the study was not con- ducted in compliance
p.000148: with those regu- lations, a brief statement of the reason for the noncompliance.
p.000148: (7) For a PMA supported solely by data from one investigation, a jus- tification showing that data
p.000148: and other information from a single investigator are sufficient to demonstrate the safe- ty and
p.000148: effectiveness of the device and to ensure reproducibility of test re- sults.
p.000148: (8)(i) A bibliography of all published reports not submitted under paragraph (b)(6) of this section,
p.000148: whether adverse or supportive, known to or that should reasonably be known to the applicant and that concern
p.000148: the safety or effec- tiveness of the device.
p.000148: (ii) An identification, discussion, and analysis of any other data, informa- tion, or report relevant to
p.000148: an evalua- tion of the safety and effectiveness of the device known to or that should rea- sonably be known
p.000148: to the applicant from any source, foreign or domestic, including information derived from in-
p.000148: vestigations other than those proposed in the application and from commer- cial marketing experience.
p.000148: (iii) Copies of such published reports or unpublished information in the pos- session of or reasonably
p.000148: obtainable by the applicant if an FDA advisory com- mittee or FDA requests.
p.000148: (9) One or more samples of the device and its components, if requested by FDA. If it is impractical to
p.000148: submit a requested sample of the device, the ap- plicant shall name the location at which FDA may examine
p.000148: and test one or more devices.
p.000148: (10) Copies of all proposed labeling for the device. Such labeling may in- clude, e.g., instructions
p.000148: for installation
p.000149: 149
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149: § 814.20
p.000149: and any information, literature, or ad- vertising that constitutes labeling under section 201(m) of the
p.000149: act.
...

p.000165: (b) Withdra al of IRB approval. A holder of an approved HDE shall notify FDA of any withdrawal of
p.000165: approval for the use of a HUD by a reviewing IRB within 5 working days after being noti- fied of the
p.000165: withdrawal of approval.
p.000165: [61 FR 33244, June 26, 1996, as amended at 63
p.000165: FR 59221, Nov. 3, 1998]
p.000165:
p.000165: § 814.126 Postapproval requirements and reports.
p.000165: (a) An HDE approved under this sub- part H shall be subject to the post- approval requirements
p.000165: and reports set forth under subpart E of this part, as applicable, with the exception of
p.000165: § 814.82(a)(7). In addition, medical de- vice reports submitted to FDA in com- pliance with the requirements
p.000165: of part 803 of this chapter shall also be sub- mitted to the IRB of record.
p.000165: (b) In addition to the reports identi- fied in paragraph (a) of this section, the holder of an approved
p.000165: HDE shall prepare and submit the following com- plete, accurate, and timely reports:
p.000165: (1) Periodic reports. An HDE applicant is required to submit reports in accord- ance with the approval order.
p.000165: Unless FDA specifies otherwise, any periodic report shall include:
p.000165: (i) An update of the information re- quired under § 814.102(a) in a separately bound volume;
p.000165: (ii) An update of the information re- quired under § 814.104(b)(2), (b)(3), and (b)(5);
p.000165: (iii) The number of devices that have been shipped or sold since initial mar- keting approval under this
p.000165: subpart H and, if the number shipped or sold ex- ceeds 4,000, an explanation and esti- mate of the
p.000165: number of devices used per patient. If a single device is used on multiple patients, the applicant shall
p.000165: submit an estimate of the number of patients treated or diagnosed using the device together with an
p.000165: explanation of the basis for the estimate;
p.000165: (iv) Information describing the appli-
p.000165: cant’s clinical experience with the de- vice since the HDE was initially ap- proved. This information
p.000165: shall include safety information that is known or reasonably should be known to the ap- plicant,
p.000165: medical device reports made under part 803 of this chapter, any data generated from the postmarketing
p.000165: studies, and information (whether pub-
p.000165: 21 CFR Ch. I (4–1–15 Edition)
p.000165: lished or unpublished) that is known or reasonably expected to be known by the applicant that may affect
p.000165: an eval- uation of the safety of the device or that may affect the statement of con- traindications,
p.000165: warnings, precautions, and adverse reactions in the device’s labeling; and
p.000165: (v) A summary of any changes made to the device in accordance with sup- plements submitted under §
p.000165: 814.108. If information provided in the periodic reports, or any other information in the
p.000165: possession of FDA, gives the agen- cy reason to believe that a device raises public health concerns
p.000165: or that the criteria for exemption are no longer met, the agency may require the HDE holder to submit
p.000165: additional infor- mation to demonstrate continued com- pliance with the HDE requirements.
p.000165: (2) Other. An HDE holder shall main- tain records of the names and addresses of the facilities to which the
...

Social / Police Officer

Searching for indicator officer:

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p.000146: (c) Research begun before effective date. FDA will accept studies sub- mitted in support of a PMA
p.000146: which have been conducted outside the United States and begun before November 19, 1986, if FDA is
p.000146: satisfied that the data are scientifically valid and that the rights, safety, and welfare of
p.000146: human subjects have not been violated.
p.000146: (d) As sole basis for marketing approval. A PMA based solely on foreign clinical data and otherwise meeting the
p.000146: cri- teria for approval under this part may be approved if:
p.000146: (1) The foreign data are applicable to the U.S. population and U.S. medical practice;
p.000146: (2) The studies have been performed by clinical investigators of recognized competence; and
p.000146: (3) The data may be considered valid without the need for an on-site inspec- tion by FDA or, if FDA
p.000146: considers such an inspection to be necessary, FDA can validate the data through an on-site in- spection or other
p.000146: appropriate means.
p.000146: (e) Consultation bet een FDA and ap- plicants. Applicants are encouraged to meet with FDA officials
p.000146: in a ‘‘pre- submission’’ meeting when approval based solely on foreign data will be sought.
p.000146: (Approved by the Office of Management and Budget under control number 0910–0231)
p.000146: [51 FR 26364, July 22, 1986; 51 FR 40415, Nov.
p.000146: 7, 1986, as amended at 51 FR 43344, Dec. 2,
p.000146: 1986]
p.000146:
p.000146: § 814.17 Service of orders.
p.000146: Orders issued under this part will be served in person by a designated officer or employee of FDA on,
p.000146: or by reg- istered mail to, the applicant or the designated agent at the applicant’s or designated
p.000146: agent’s last known address in FDA’s records.
p.000146:
p.000146: § 814.19 Product development protocol (PDP).
p.000146: A class III device for which a product development protocol has been de- clared completed by FDA
p.000146: under this chapter will be considered to have an approved PMA.
p.000146:
p.000146: Subpart B—Premarket Approval Application (PMA)
p.000146: § 814.20 Application.
p.000146: (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside
p.000146: or have a place of business within the United States, the PMA shall be countersigned by an authorized
p.000146: representative resid- ing or maintaining a place of business in the United States and shall identify the
p.000146: representative’s name and address.
p.000146: (b) Unless the applicant justifies an omission in accordance with paragraph
p.000146: (d) of this section, a PMA shall include:
p.000146: (1) The name and address of the ap- plicant.
p.000146: (2) A table of contents that specifies the volume and page number for each item referred to in the
p.000146: table. A PMA shall include separate sections on non- clinical laboratory studies and on clin- ical
p.000146: investigations involving human subjects. A PMA shall be submitted in six copies each bound in one or
p.000146: more numbered volumes of reasonable size. The applicant shall include informa- tion that it believes to
p.000146: be trade secret or confidential commercial or financial information in all copies of the PMA and identify in
...

Social / Property Ownership

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p.000154: § 14.22(g). The advisory committee re- port and recommendation may be in the form of a meeting transcript
p.000154: signed by the chairperson of the committee.
p.000154: (c) FDA will complete its review of the PMA and the advisory committee report and recommendation and,
p.000154: with- in the later of 180 days from the date of filing of the PMA under § 814.42 or the number of days after
p.000154: the date of filing as determined under § 814.37(c), issue an approval order under paragraph (d) of this
p.000154: section, an approvable letter under paragraph (e) of this section, a not ap- provable letter under paragraph
p.000154: (f) of this section, or an order denying ap- proval of the application under
p.000154: § 814.45(a).
p.000154: (d)(1) FDA will issue to the applicant an order approving a PMA if none of the reasons in § 814.45 for
p.000154: denying ap- proval of the application applies. FDA will approve an application on the basis of draft
p.000154: final labeling if the only deficiencies in the application concern editorial or similar minor deficiencies
p.000154: in the draft final labeling. Such ap- proval will be conditioned upon the ap- plicant incorporating the
p.000154: specified la- beling changes exactly as directed and upon the applicant submitting to FDA a copy of the
p.000154: final printed labeling be- fore marketing. FDA will also give the public notice of the order, including
p.000154: notice of and opportunity for any in-
p.000154:
p.000154: terested persons to request review under section 515(d)(3) of the act. The notice of approval
p.000154: will be placed on FDA’s home page on the Internet (http:// .fda.gov), and it will
p.000154: state that a detailed summary of informa- tion respecting the safety and effec- tiveness of the
p.000154: device, which was the basis for the order approving the PMA, including information about any ad- verse
p.000154: effects of the device on health, is available on the Internet and has been placed on public display, and
p.000154: that cop- ies are available upon request. FDA will publish in the FEDERAL REGISTER after each quarter
p.000154: a list of the approv- als announced in that quarter. When a notice of approval is published, data
p.000154: and information in the PMA file will be available for public disclosure in ac- cordance with § 814.9.
p.000154: (2) A request for copies of the current PMA approvals and denials document and for copies of summaries of
p.000154: safety and effectiveness shall be sent in writ- ing to the Division of Dockets Manage- ment (HFA–305), Food
p.000154: and Drug Ad- ministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
p.000154: (e) FDA will send the applicant an approvable letter if the application substantially meets the
p.000154: requirements of this part and the agency believes it can approve the application if specific additional
p.000154: information is submitted or specific conditions are agreed to by the applicant.
p.000154: (1) The approvable letter will de- scribe the information FDA requires to be provided by the
p.000154: applicant or the conditions the applicant is required to meet to obtain approval. For example, FDA may
p.000154: require, as a condition to ap- proval:
...

p.000155: the study; or
p.000155: (5) Any clinical investigation involv- ing human subjects described in the PMA, subject to the
p.000155: institutional re- view board regulations in part 56 or in- formed consent regulations in part 50, was not
p.000155: conducted in compliance with those regulations such that the rights or safety of human subjects were not
p.000155: adequately protected.
p.000155: (b) FDA will issue any order denying approval of the PMA in accordance with § 814.17. The order
p.000155: will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under
p.000155: section 515(d)(2) of the act and the regulations under this part, and, where practical, will identify
p.000155: measures required to place the PMA in approvable form. The order will include a notice of an opportunity to
p.000155: request review under section 515(d)(4) of the act.
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: Food and Drug Administration, HHS § 814.46
p.000156:
p.000156:
p.000156: (c) FDA will use the criteria specified in § 860.7 to determine the safety and effectiveness of a device
p.000156: in deciding whether to approve or deny approval of a PMA. FDA may use information other than that submitted
p.000156: by the appli- cant in making such determination.
p.000156: (d)(1) FDA will give the public notice of an order denying approval of the PMA. The notice will be
p.000156: placed on the FDA’s home page on the Internet (http:// .fda.gov), and it will state
p.000156: that a detailed summary of informa- tion respecting the safety and effec- tiveness of the device,
p.000156: including infor- mation about any adverse effects of the device on health, is available on the Internet and
p.000156: has been placed on public display and that copies are available upon request. FDA will publish in the
p.000156: FEDERAL REGISTER after each quarter a list of the denials announced in that quarter. When a notice of
p.000156: denial of ap- proval is made publicly available, data and information in the PMA file will be available for
p.000156: public disclosure in ac- cordance with § 814.9.
p.000156: (2) A request for copies of the current PMA approvals and denials document and copies of summaries of safety
p.000156: and effectiveness shall be sent in writing to the Freedom of Information Staff’s ad- dress listed on the Agency’s
p.000156: Web site at http:// .fda.gov.
p.000156: (e) FDA will issue an order denying approval of a PMA after an approvable or not approvable letter has
p.000156: been sent and the applicant:
p.000156: (1) Submits a requested amendment but any ground for denying approval of the application under section
p.000156: 515(d)(2) of the act still applies; or
p.000156: (2) Notifies FDA in writing that the requested amendment will not be sub- mitted; or
p.000156: (3) Petitions for review under section 515(d)(3) of the act by filing a petition in the form of a petition for
p.000156: reconsider- ation under § 10.33.
p.000156: [51 FR 26364, July 22, 1986, as amended at 63
p.000156: FR 4572, Jan. 30, 1998; 73 FR 34859, June 19,
p.000156: 2008; 76 FR 31470, June 1, 2011; 79 FR 68115,
p.000156: Nov. 14, 2014]
p.000156:
...

Social / Threat of Stigma

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p.000143: pending PMA supplement.
p.000143: (g) PMA supplement means a supple- mental application to an approved PMA for approval of a change or
p.000143: modi- fication in a class III medical device, including all information submitted with or
p.000143: incorporated by reference therein.
p.000143: (h) Person includes any individual, partnership, corporation, association, scientific or academic
p.000143: establishment, Government agency, or organizational unit thereof, or any other legal entity.
p.000143: (i) Statement of material fact means a representation that tends to show that the safety or effectiveness
p.000143: of a device is more probable than it would be in the absence of such a representation. A false affirmation or
p.000143: silence or an omis-
p.000143: 21 CFR Ch. I (4–1–15 Edition)
p.000143: sion that would lead a reasonable per- son to draw a particular conclusion as to the safety or
p.000143: effectiveness of a de- vice also may be a false statement of material fact, even if the statement
p.000143: was not intended by the person making it to be misleading or to have any pro- bative effect.
p.000143: (j) 30-day PMA supplement means a supplemental application to an ap- proved PMA in
p.000143: accordance with
p.000143: § 814.39(e).
p.000143: (k) Reasonable probability means that it is more likely than not that an event will occur.
p.000143: (l) Serious, adverse health consequences means any significant adverse experi- ence, including those which
p.000143: may be ei- ther life-threatening or involve perma- nent or long term injuries, but exclud- ing injuries
p.000143: that are nonlife-threat- ening and that are temporary and rea- sonably reversible.
p.000143: (m) HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device
p.000143: exemption from the effectiveness re- quirements of sections 514 and 515 of the act as authorized
p.000143: by section 520(m)(2) of the act.
p.000143: (n) HUD (humanitarian use device) means a medical device intended to benefit patients in the
p.000143: treatment or di- agnosis of a disease or condition that affects or is manifested in fewer than 4,000
p.000143: individuals in the United States per year.
p.000143: (o) Ne ly acquired information means data, analyses, or other information not previously submitted to
p.000143: the agen- cy, which may include (but are not lim- ited to) data derived from new clinical studies, reports of
p.000143: adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the stud- ies, events
p.000143: or analyses reveal risks of a different type or greater severity or frequency than previously included in
p.000143: submissions to FDA.
p.000143: (p) Human cell, tissue, or cellular or tis- sue-based product (HCT/P) regulated as a device means an HCT/P as
p.000143: defined in
p.000143: § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a
p.000143: device.
p.000143: (q) Unique device identifier (UDI)
p.000143: means an identifier that adequately
p.000144: 144
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: Food and Drug Administration, HHS § 814.9
p.000144:
p.000144:
...

Social / Youth/Minors

Searching for indicator minor:

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p.000154: forth under § 814.37(b), or with a panel to respond to questions that may be posed by panel members or to
p.000154: provide additional information to the panel. FDA will maintain a record of all communications with the
p.000154: appli- cant and with the panel.
p.000154: (b) The advisory committee shall
p.000154: submit a report to FDA which includes the committee’s recommendation and the basis for such recommendation on
p.000154: the PMA. Before submission of this re- port, the committee shall hold a public meeting to review the PMA in
p.000154: accord- ance with part 14. This meeting may be held by a telephone conference under
p.000154: § 14.22(g). The advisory committee re- port and recommendation may be in the form of a meeting transcript
p.000154: signed by the chairperson of the committee.
p.000154: (c) FDA will complete its review of the PMA and the advisory committee report and recommendation and,
p.000154: with- in the later of 180 days from the date of filing of the PMA under § 814.42 or the number of days after
p.000154: the date of filing as determined under § 814.37(c), issue an approval order under paragraph (d) of this
p.000154: section, an approvable letter under paragraph (e) of this section, a not ap- provable letter under paragraph
p.000154: (f) of this section, or an order denying ap- proval of the application under
p.000154: § 814.45(a).
p.000154: (d)(1) FDA will issue to the applicant an order approving a PMA if none of the reasons in § 814.45 for
p.000154: denying ap- proval of the application applies. FDA will approve an application on the basis of draft
p.000154: final labeling if the only deficiencies in the application concern editorial or similar minor deficiencies
p.000154: in the draft final labeling. Such ap- proval will be conditioned upon the ap- plicant incorporating the
p.000154: specified la- beling changes exactly as directed and upon the applicant submitting to FDA a copy of the
p.000154: final printed labeling be- fore marketing. FDA will also give the public notice of the order, including
p.000154: notice of and opportunity for any in-
p.000154:
p.000154: terested persons to request review under section 515(d)(3) of the act. The notice of approval
p.000154: will be placed on FDA’s home page on the Internet (http:// .fda.gov), and it will
p.000154: state that a detailed summary of informa- tion respecting the safety and effec- tiveness of the
p.000154: device, which was the basis for the order approving the PMA, including information about any ad- verse
p.000154: effects of the device on health, is available on the Internet and has been placed on public display, and
p.000154: that cop- ies are available upon request. FDA will publish in the FEDERAL REGISTER after each quarter
p.000154: a list of the approv- als announced in that quarter. When a notice of approval is published, data
p.000154: and information in the PMA file will be available for public disclosure in ac- cordance with § 814.9.
p.000154: (2) A request for copies of the current PMA approvals and denials document and for copies of summaries of
p.000154: safety and effectiveness shall be sent in writ- ing to the Division of Dockets Manage- ment (HFA–305), Food
p.000154: and Drug Ad- ministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
...

p.000162: order denying approval (under § 814.118).
p.000162: [63 FR 59221, Nov. 3, 1998]
p.000162:
p.000162: § 814.116 Procedures for review of an HDE.
p.000162: (a) Substantive revie . FDA will begin substantive review of an HDE after the HDE is accepted for
p.000162: filing under
p.000162: § 814.112. FDA may refer an original HDE application to a panel on its own initiative, and shall do
p.000162: so upon the re- quest of an applicant, unless FDA de- termines that the application substan- tially
p.000162: duplicates information pre- viously reviewed by a panel. If the HDE is referred to a panel, the agency
p.000162: shall follow the procedures set forth under
p.000162: § 814.44, with the exception that FDA will complete its review of the HDE and the advisory committee report
p.000162: and recommendations within 75 days from receipt of an HDE that is accepted for filing under § 814.112 or
p.000162: the date of fil- ing as determined under § 814.106, whichever is later. Within the later of these
p.000162: two timeframes, FDA will issue an approval order under paragraph (b) of this section, an approvable
p.000162: letter under paragraph (c) of this section, a not approvable letter under paragraph
p.000162: (d) of this section, or an order denying approval of the application under
p.000162: § 814.118(a).
p.000162: (b) Approval order. FDA will issue to the applicant an order approving an HDE if none of the
p.000162: reasons in § 814.118 for denying approval of the application applies. FDA will approve an applica- tion on the
p.000162: basis of draft final labeling if the only deficiencies in the applica- tion concern editorial or similar minor
p.000162: deficiencies in the draft final labeling. Such approval will be conditioned upon the applicant incorporating
p.000162: the speci- fied labeling changes exactly as di- rected and upon the applicant submit- ting to FDA a
p.000162: copy of the final printed labeling before marketing. The notice of approval of an HDE will be published in the
p.000162: FEDERAL REGISTER in accord- ance with the rules and policies appli- cable to PMA’s submitted
p.000162: under
p.000162: § 814.20. Following the issuance of an
p.000162: approval order, data and information in the HDE file will be available for
p.000163: 163
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163: § 814.118
p.000163: public disclosure in accordance with
p.000163: § 814.9(b) through (h), as applicable.
p.000163: (c) Approvable letter. FDA will send the applicant an approvable letter if the application substantially
p.000163: meets the requirements of this subpart and the agency believes it can approve the ap- plication if specific
p.000163: additional informa- tion is submitted or specific conditions are agreed to by the applicant. The ap- provable letter
p.000163: will describe the infor- mation FDA requires to be provided by the applicant or the conditions the ap- plicant
p.000163: is required to meet to obtain approval. For example, FDA may re- quire as a condition to approval:
p.000163: (1) The submission of certain infor- mation identified in the approvable let- ter, e.g., final labeling;
p.000163: (2) The submission of additional in- formation concerning pediatric uses of the device, as required by §
p.000163: 814.20(b)(13);
p.000163: (3) Restrictions imposed on the de- vice under section 520(e) of the act;
...

Social / employees

Searching for indicator employees:

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p.000158: cards given to patients if necessary to protect the public health.
p.000158: (5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace
p.000158: patients if such information is necessary to pro- tect the public health. Under section 519(a)(4) of the
p.000158: act, FDA will require that the identity of any patient be dis- closed in records maintained under this paragraph
p.000158: only to the extent required for the medical welfare of the indi- vidual, to determine the safety
p.000158: or ef- fectiveness of the device, or to verify a record, report, or information sub- mitted to the agency.
p.000158: (6) Maintenance of records for speci-
p.000158: fied periods of time and organization and indexing of records into identifi- able files to enable FDA to
p.000158: determine whether there is reasonable assurance of the continued safety and effective- ness of the device.
p.000158: (7) Submission to FDA at intervals specified in the approval order of peri- odic reports containing
p.000158: the informa- tion required by § 814.84(b).
p.000158: (8) Batch testing of the device.
p.000158: (9) Such other requirements as FDA determines are necessary to provide reasonable assurance, or continued
p.000158: rea- sonable assurance, of the safety and ef- fectiveness of the device.
p.000158: (b) An applicant shall grant to FDA access to any records and reports re- quired under the provisions
p.000158: of this part, and shall permit authorized FDA employees to copy and verify such records and reports
p.000158: and to inspect at a reasonable time and in a reasonable manner all manufacturing facilities to verify
p.000158: that the device is being manu- factured, stored, labeled, and shipped under approved conditions.
p.000158: (c) Failure to comply with any post- approval requirement constitutes a
p.000158:
p.000158: ground for withdrawal of approval of a PMA.
p.000158: (Approved by the Office of Management and Budget under control number 0910–0231)
p.000158: [51 FR 26364, July 22, 1986, as amended at 51
p.000158: FR 43344, Dec. 2, 1986]
p.000158:
p.000158: § 814.84 Reports.
p.000158: (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other
p.000158: require- ments applicable to the device by other regulations in this subchapter or by order approving the
p.000158: device.
p.000158: (b) Unless FDA specifies otherwise, any periodic report shall:
p.000158: (1) Identify changes described in
p.000158: § 814.39(a) and changes required to be reported to FDA under § 814.39(b).
p.000158: (2) Contain a summary and bibliog- raphy of the following information not previously submitted as part
p.000158: of the PMA:
p.000158: (i) Unpublished reports of data from any clinical investigations or nonclin- ical laboratory studies
p.000158: involving the device or related devices and known to or that reasonably should be known to the applicant.
p.000158: (ii) Reports in the scientific lit- erature concerning the device and known to or that
p.000158: reasonably should be known to the applicant. If, after re- viewing the summary and bibliog- raphy,
...

Social / orphan

Searching for indicator orphan:

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p.000159: the disease or condition that the device is intended to treat, diagnose, or cure; and
p.000159: (2) The number of affected pediatric patients.
p.000159: (d) Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any
p.000159: non-HUD use shall submit a PMA as re- quired under § 814.20, or a premarket notification as required under
p.000159: part 807 of this chapter.
p.000159: (e) Obtaining marketing approval for a HUD involves two steps:
p.000159: (1) Obtaining designation of the de- vice as a HUD from FDA’s Office of Or- phan Products Development, and
p.000159: (2) Submitting an HDE to the Office of Device Evaluation (ODE), Center for Devices and Radiological
p.000159: Health (CDRH), the Center for Biologics Eval- uation and Research (CBER), or the Center for Drug
p.000159: Evaluation and Re- search (CDER), as applicable.
p.000159: (f) A person granted an exemption under section 520(m) of the act shall
p.000159: 21 CFR Ch. I (4–1–15 Edition)
p.000159: submit periodic reports as described in
p.000159: § 814.126(b).
p.000159: (g) FDA may suspend or withdraw ap- proval of an HDE after providing notice and an opportunity for an
p.000159: informal hearing.
p.000159: [61 FR 33244, June 26, 1996, as amended at 63
p.000159: FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25,
p.000159: 2008; 79 FR 1740, Jan. 10, 2014]
p.000159: § 814.102 Designation of HUD status.
p.000159: (a) Request for designation. Prior to submitting an HDE application, the ap- plicant shall submit a request for
p.000159: HUD designation to FDA’s Office of Orphan Products Development. The request shall contain the following:
p.000159: (1) A statement that the applicant re- quests HUD designation for a rare dis- ease or condition or a valid subset
p.000159: of a disease or condition which shall be identified with specificity;
p.000159: (2) The name and address of the ap- plicant, the name of the applicant’s primary contact person and/or
p.000159: resident agent, including title, address, and telephone number;
p.000159: (3) A description of the rare disease or condition for which the device is to be used, the proposed
p.000159: indication or in- dications for use of the device, and the reasons why such therapy is needed. If the device is
p.000159: proposed for an indication that represents a subset of a common disease or condition, a demonstration that
p.000159: the subset is medically plausible should be included;
p.000159: (4) A description of the device and a
p.000159: discussion of the scientific rationale for the use of the device for the rare disease or condition; and
p.000159: (5) Documentation, with appended authoritative references, to dem- onstrate that the device is
p.000159: designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 people
p.000159: in the United States per year. If the device is for diagnostic purposes, the documentation must demonstrate
p.000159: that fewer than 4,000 pa- tients per year would be subjected to diagnosis by the device in the United
p.000159: States. Authoritative references in- clude literature citations in specialized medical journals,
p.000159: textbooks, special- ized medical society proceedings, or governmental statistics publications. When no
...

p.000160: on the in- formation submitted;
p.000160: (2) Return the request to the appli- cant pending further review upon sub- mission of additional
p.000160: information. This action will ensue if the request is in- complete because it does not on its face contain all
p.000160: of the information required under § 814.102(a). Upon receipt of this additional information, the review pe-
p.000160: riod may be extended up to 45 days; or
p.000160: (3) Disapprove the request for HUD designation based on a substantive re- view of the information
p.000160: submitted. FDA may disapprove a request for HUD designation if:
p.000160: (i) There is insufficient evidence to support the estimate that the disease or condition for which the device
p.000160: is de- signed to treat or diagnose affects or is manifested in fewer than 4,000 people in the United States per year;
p.000160: (ii) FDA determines that, for a diag- nostic device, 4,000 or more patients in the United States would
p.000160: be subjected to diagnosis using the device per year; or
p.000160: (iii) FDA determines that the patient population defined in the request is not a medically plausible subset of a larger
p.000160: population.
p.000160: (c) Revocation of designation. FDA may revoke a HUD designation if the agency finds that:
p.000160: (1) The request for designation con- tained an untrue statement of material fact or omitted material
p.000160: information; or
p.000160: (2) Based on the evidence available, the device is not eligible for HUD des- ignation.
p.000160: (d) Submission. The applicant shall submit two copies of a completed, dated, and signed request
p.000160: for HUD des- ignation to: Office of Orphan Products Development (HF–35), Food and Drug Administration,
p.000160: 5600 Fishers Lane, Rockville, MD 20857.
p.000160:
p.000160: § 814.104 Original applications.
p.000160: (a) United States applicant or represent- ative. The applicant or an authorized representative shall sign the
p.000160: HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be
p.000160: countersigned by an authorized representative resid- ing or maintaining a place of business in the United
p.000160: States and shall identify the representative’s name and address.
p.000160: (b) Contents. Unless the applicant jus- tifies an omission in accordance with paragraph (d) of this section,
p.000160: an HDE shall include:
p.000160: (1) A copy of or reference to the de- termination made by FDA’s Office of Orphan Products Development
p.000160: (in ac- cordance with § 814.102) that the device qualifies as a HUD;
p.000160: (2) An explanation of why the device would not be available unless an HDE were granted and a statement
p.000160: that no comparable device (other than another HUD approved under this subpart or a device under an approved
p.000160: IDE) is avail- able to treat or diagnose the disease or condition. The application also shall contain a
p.000160: discussion of the risks and benefits of currently available devices or alternative forms of treatment in
p.000160: the United States;
p.000160: (3) An explanation of why the prob- able benefit to health from the use of the device outweighs the risk
p.000160: of injury or illness from its use, taking into ac- count the probable risks and benefits of currently
p.000160: available devices or alter- native forms of treatment. Such expla- nation shall include a description, ex-
p.000160: planation, or theory of the underlying disease process or condition, and known or postulated
p.000160: mechanism(s) of action of the device in relation to the disease process or condition;
p.000160: (4) All of the information required to be submitted under § 814.20(b), except that:
p.000160: (i) In lieu of the summaries, conclu- sions, and results from clinical inves- tigations
p.000160: required under
p.000160: §§ 814.20(b)(3)(v)(B), (b)(3)(vi), and
p.000160: (b)(6)(ii), the applicant shall include the summaries, conclusions, and re- sults of all clinical
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

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p.000151: fected’’;
p.000151: (ii) The PMA supplement provides a full explanation of the basis for the changes;
p.000152: 152
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152: Food and Drug Administration, HHS § 814.40
p.000152:
p.000152:
p.000152: (iii) The applicant has received ac- knowledgement from FDA of receipt of the supplement; and
p.000152: (iv) The PMA supplement specifically identifies the date that such changes are being effected.
p.000152: (2) The following changes are per- mitted by paragraph (d)(1) of this sec- tion:
p.000152: (i) Labeling changes that add or strengthen a contraindication, warn- ing, precaution, or
p.000152: information about an adverse reaction for which there is reasonable evidence of a causal asso- ciation.
p.000152: (ii) Labeling changes that add or strengthen an instruction that is in- tended to enhance the safe
p.000152: use of the device.
p.000152: (iii) Labeling changes that delete misleading, false, or unsupported indi- cations.
p.000152: (iv) Changes in quality controls or manufacturing process that add a new specification or test method, or
p.000152: other- wise provide additional assurance of purity, identity, strength, or reli- ability of the
p.000152: device.
p.000152: (e)(1) FDA will identify a change to a device for which an applicant has an approved PMA and for which a
p.000152: PMA supplement under paragraph (a) is not required. FDA will identify such a change in an advisory
p.000152: opinion under
p.000152: § 10.85, if the change applies to a ge- neric type of device, or in correspond- ence to the applicant, if
p.000152: the change ap- plies only to the applicant’s device. FDA will require that a change for which a
p.000152: PMA supplement under para- graph (a) is not required be reported to FDA in:
p.000152: (i) A periodic report under § 814.84 or
p.000152: (ii) A 30-day PMA supplement under this paragraph.
p.000152: (2) FDA will identify, in the advisory opinion or correspondence, the type of information that is to be
p.000152: included in the report or 30-day PMA supplement. If the change is required to be reported to FDA in a periodic
p.000152: report, the change may be made before it is reported to FDA. If the change is required to be re- ported in a
p.000152: 30-day PMA supplement, the change may be made 30 days after FDA files the 30-day PMA supplement
p.000152: unless FDA requires the PMA holder to provide additional information, in- forms the PMA holder that the
p.000152: supple-
p.000152:
p.000152: ment is not approvable, or disapproves the supplement. The 30-day PMA sup- plement shall follow the
p.000152: instructions in the correspondence or advisory opin- ion. Any 30-day PMA supplement that does not meet the
p.000152: requirements of the correspondence or advisory opinion will not be filed and, therefore, will not be deemed
p.000152: approved 30 days after re- ceipt.
p.000152: (f) Under section 515(d) of the act,
p.000152: modifications to manufacturing proce- dures or methods of manufacture that affect the safety and
p.000152: effectiveness of a device subject to an approved PMA do not require submission of a PMA sup- plement
p.000152: under paragraph (a) of this section and are eligible to be the sub- ject of a 30-day notice. A
p.000152: 30-day notice shall describe in detail the change, summarize the data or information supporting the
p.000152: change, and state that the change has been made in accord- ance with the requirements of part 820 of
p.000152: this chapter. The manufacturer may distribute the device 30 days after the date on which FDA receives the
p.000152: 30-day notice, unless FDA notifies the appli- cant within 30 days from receipt of the notice that the notice
p.000152: is not adequate. If the notice is not adequate, FDA shall inform the applicant in writing that a 135-day PMA
p.000152: supplement is needed and shall describe what further information or action is required for acceptance of such
p.000152: change. The number of days under review as a 30-day notice shall be de- ducted from the 135-day PMA supple-
p.000152: ment review period if the notice meets appropriate content requirements for a PMA supplement.
p.000152: (g) The submission and grant of a
p.000152: written request for an exception or al- ternative under § 801.128 or § 809.11 of this chapter
p.000152: satisfies the requirement in paragraph (a) of this section.
p.000152: [51 FR 26364, July 22, 1986, as amended at 51
p.000152: FR 43344, Dec. 2, 1986; 63 FR 54044, Oct. 8, 1998;
...

General/Other / Public Emergency

Searching for indicator emergency:

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p.000164:
p.000164: reasons and in the same manner as pre- scribed for PMA’s in § 814.47.
p.000164: [63 FR 59221, Nov. 3, 1998]
p.000164:
p.000164: § 814.122 Confidentiality of data and information.
p.000164: (a) Requirement for disclosure. The ‘‘HDE file’’ includes all data and infor- mation submitted with or
p.000164: referenced in the HDE, any IDE incorporated into the HDE, any HDE amendment or sup- plement, any
p.000164: report submitted under
p.000164: § 814.126, any master file, or any other related submission. Any record in the HDE file will be
p.000164: available for public disclosure in accordance with the pro- visions of this section and part 20 of this
p.000164: chapter.
p.000164: (b) Extent of disclosure. Disclosure by FDA of the existence and contents of an HDE file shall be
p.000164: subject to the same rules that pertain to PMA’s under § 814.9(b) through (h), as applica- ble.
p.000164: § 814.124 Institutional Review Board requirements.
p.000164: (a) IRB approval. The HDE holder is responsible for ensuring that a HUD approved under this subpart is
p.000164: adminis- tered only in facilities having an Insti- tutional Review Board (IRB) con- stituted and acting
p.000164: pursuant to part 56 of this chapter, including continuing review of use of the device. In addition, a HUD
p.000164: may be administered only if such use has been approved by the IRB located at the facility or by a similarly
p.000164: constituted IRB that has agreed to oversee such use and to which the local IRB has deferred in a letter to
p.000164: the HDE holder, signed by the IRB chair or an authorized designee. If, however, a phy- sician in an emergency
p.000164: situation deter- mines that approval from an IRB can- not be obtained in time to prevent seri- ous harm or death
p.000164: to a patient, a HUD may be administered without prior ap- proval by the IRB located at the facil- ity or
p.000164: by a similarly constituted IRB that has agreed to oversee such use. In such an emergency situation, the phy-
p.000164: sician shall, within 5 days after the use of the device, provide written notifica- tion to the chairman of the IRB
p.000164: of such use. Such written notification shall in- clude the identification of the patient involved, the date on
p.000164: which the device was used, and the reason for the use.
p.000165: 165
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: § 814.126
p.000165: (b) Withdra al of IRB approval. A holder of an approved HDE shall notify FDA of any withdrawal of
p.000165: approval for the use of a HUD by a reviewing IRB within 5 working days after being noti- fied of the
p.000165: withdrawal of approval.
p.000165: [61 FR 33244, June 26, 1996, as amended at 63
p.000165: FR 59221, Nov. 3, 1998]
p.000165:
p.000165: § 814.126 Postapproval requirements and reports.
p.000165: (a) An HDE approved under this sub- part H shall be subject to the post- approval requirements
p.000165: and reports set forth under subpart E of this part, as applicable, with the exception of
p.000165: § 814.82(a)(7). In addition, medical de- vice reports submitted to FDA in com- pliance with the requirements
p.000165: of part 803 of this chapter shall also be sub- mitted to the IRB of record.
p.000165: (b) In addition to the reports identi- fied in paragraph (a) of this section, the holder of an approved
p.000165: HDE shall prepare and submit the following com- plete, accurate, and timely reports:
p.000165: (1) Periodic reports. An HDE applicant is required to submit reports in accord- ance with the approval order.
p.000165: Unless FDA specifies otherwise, any periodic report shall include:
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.000143: 814.15 Research conducted outside the United States.
p.000143: 814.17 Service of orders.
p.000143: 814.19 Product development protocol (PDP).
p.000143: Subpart B—Premarket Approval Application (PMA)
p.000143: 814.20 Application.
p.000143: 814.37 PMA amendments and resubmitted PMAs.
p.000143: 814.39 PMA supplements.
p.000143: Subpart C—FDA Action on a PMA
p.000143: 814.40 Time frames for reviewing a PMA.
p.000143: 814.42 Filing a PMA.
p.000143: 814.44 Procedures for review of a PMA.
p.000143: 814.45 Denial of approval of a PMA.
p.000143: 814.46 Withdrawal of approval of a PMA.
p.000143: 814.47 Temporary suspension of approval of a PMA.
p.000143: Subpart D—Administrative Review
p.000143: [Reserved]
p.000143: Subpart E—Postapproval Requirements
p.000143: 814.80 General.
p.000143: 814.82 Postapproval requirements.
p.000143: 814.84 Reports.
p.000143: Subparts F–G [Reserved]
p.000143: Subpart H—Humanitarian Use Devices
p.000143: 814.100 Purpose and scope.
p.000143: 814.102 Designation of HUD status.
p.000143: 814.104 Original applications.
p.000143: 814.106 HDE amendments and resubmitted HDE’s.
p.000143: 814.108 Supplemental applications.
p.000143: 814.110 New indications for use.
p.000143: 814.112 Filing an HDE.
p.000143: 814.114 Timeframes for reviewing an HDE.
p.000143: 814.116 Procedures for review of an HDE.
p.000143: 814.118 Denial of approval or withdrawal of approval of an HDE.
p.000143: 814.120 Temporary suspension of approval of an HDE.
p.000143: 814.122 Confidentiality of data and informa- tion.
p.000143: 814.124 Institutional Review Board require- ments.
p.000143:
p.000143: 814.126 Postapproval requirements and re- ports.
p.000143: AUTHORITY: 21 U.S.C. 351, 352, 353, 360, 360c–
p.000143: 360j, 371, 372, 373, 374, 375, 379, 379e, 381.
p.000143: SOURCE: 51 FR 26364, July 22, 1986, unless
p.000143: otherwise noted.
p.000143:
p.000143: Subpart A—General
p.000143: § 814.1 Scope.
p.000143: (a) This section implements sections
p.000143: 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended
p.000143: for human use.
p.000143: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000143: title 21, unless otherwise noted.
p.000143: (c) This part applies to any class III medical device, unless exempt under section 520(g) of the act,
p.000143: that:
p.000143: (1) Was not on the market (intro- duced or delivered for introduction into commerce for commercial
p.000143: distribution) before May 28, 1976, and is not substan- tially equivalent to a device on the market before
p.000143: May 28, 1976, or to a de- vice first marketed on, or after that date, which has been classified
p.000143: into class I or class II; or
p.000143: (2) Is required to have an approved premarket approval application (PMA) or a declared completed product
p.000143: devel- opment protocol under a regulation issued under section 515(b) of the act; or
p.000143: (3) Was regulated by FDA as a new drug or antibiotic drug before May 28, 1976, and therefore is
p.000143: governed by sec- tion 520(1) of the act.
p.000143: (d) This part amends the conditions to approval for any PMA approved be- fore the effective date of this
...

p.000156: withdraw ap- proval of a PMA.
p.000156: (c) Before issuing an order with- drawing approval of a PMA, FDA will issue the holder of the
p.000156: approved appli- cation a notice of opportunity for an informal hearing under part 16.
p.000156: (d) If the applicant does not request a hearing or if after the part 16 hearing is held the agency decides
p.000156: to proceed with the withdrawal, FDA will issue to the holder of the approved application an order withdrawing
p.000156: approval of the application. The order will be issued under § 814.17, will state each ground for
p.000156: withdrawing approval, and will in- clude a notice of an opportunity for ad- ministrative review under
p.000156: section 515(e)(2) of the act.
p.000156: (e) FDA will give the public notice of an order withdrawing approval of a PMA. The notice will be
p.000156: published in
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: § 814.47
p.000157: the FEDERAL REGISTER and will state that a detailed summary of informa- tion respecting the safety
p.000157: and effec- tiveness of the device, including infor- mation about any adverse effects of the device on health,
p.000157: has been placed on public display and that copies are available upon request. When a notice of
p.000157: withdrawal of approval is published, data and information in the PMA file will be available for public
p.000157: disclosure in accordance with § 814.9.
p.000157: § 814.47 Temporary suspension of ap- proval of a PMA.
p.000157: (a) Scope. (1) This section describes the procedures that FDA will follow in exercising its authority
p.000157: under section 515(e)(3) of the act (21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as
p.000157: well as any PMA supple- ment(s), for a medical device.
p.000157: (2) FDA will issue an order tempo- rarily suspending approval of a PMA if FDA determines that there is a reason-
p.000157: able probability that continued dis- tribution of the device would cause se- rious, adverse health
p.000157: consequences or death.
p.000157: (b) Regulatory hearing. (1) If FDA be- lieves that there is a reasonable prob- ability that the
p.000157: continued distribution of a device subject to an approved PMA would cause serious, adverse health consequences
p.000157: or death, FDA may ini- tiate and conduct a regulatory hearing to determine whether to issue an order temporarily
p.000157: suspending approval of the PMA.
p.000157: (2) Any regulatory hearing to deter- mine whether to issue an order tempo- rarily suspending approval of
p.000157: a PMA shall be initiated and conducted by FDA pursuant to part 16 of this chap- ter. If FDA believes
p.000157: that immediate ac- tion to remove a dangerous device from the market is necessary to protect the public health,
p.000157: the agency may, in ac- cordance with § 16.60(h) of this chapter, waive, suspend, or modify any part 16
p.000157: procedure pursuant to § 10.19 of this chapter.
p.000157: (3) FDA shall deem the PMA holder’s
p.000157: failure to request a hearing within the timeframe specified by FDA in the no- tice of opportunity for
p.000157: hearing to be a waiver.
p.000157: (c) Temporary suspension order. If the PMA holder does not request a regu-
p.000157: 21 CFR Ch. I (4–1–15 Edition)
p.000157: latory hearing or if, after the hearing, and after consideration of the adminis- trative record of the
p.000157: hearing, FDA de- termines that there is a reasonable probability that the continued dis-
p.000157: tribution of a device under an approved PMA would cause serious, adverse health consequences or
p.000157: death, the agency shall, under the authority of section 515(e)(3) of the act, issue an order
p.000157: to the PMA holder temporarily suspending approval of the PMA.
p.000157: (d) Permanent ithdra al of approval of the PMA. If FDA issues an order tem- porarily suspending approval of a
p.000157: PMA, the agency shall proceed expeditiously, but within 60 days, to hold a hearing on whether to permanently
p.000157: withdraw ap- proval of the PMA in accordance with section 515(e)(1) of the act and the pro- cedures set out in §
p.000157: 814.46.
p.000157: [61 FR 15190, Apr. 5, 1996]
p.000157:
p.000157: Subpart D—Administrative Review
p.000157: [Reserved]
p.000157: Subpart E—Postapproval Requirements
p.000157: § 814.80 General.
p.000157: A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that
p.000157: is in- consistent with any conditions to ap- proval specified in the PMA approval order for the device.
p.000157: § 814.82 Postapproval requirements.
p.000157: (a) FDA may impose postapproval re- quirements in a PMA approval order or by regulation at the time of approval
p.000157: of the PMA or by regulation subse- quent to approval. Postapproval re- quirements may include as
p.000157: a condition to approval of the device:
p.000157: (1) Restriction of the sale, distribu- tion, or use of the device as provided by section 515(d)(1)(B)(ii) or
p.000157: 520(e) of the act.
p.000157: (2) Continuing evaluation and peri- odic reporting on the safety, effective- ness, and reliability of
p.000157: the device for its intended use. FDA will state in the PMA approval order the reason or pur- pose for
p.000157: such requirement and the number of patients to be evaluated and the reports required to be submitted.
p.000158: 158
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
...


Orphaned Trigger Words



p.000156: 515(d)(2) of the act still applies; or
p.000156: (2) Notifies FDA in writing that the requested amendment will not be sub- mitted; or
p.000156: (3) Petitions for review under section 515(d)(3) of the act by filing a petition in the form of a petition for
p.000156: reconsider- ation under § 10.33.
p.000156: [51 FR 26364, July 22, 1986, as amended at 63
p.000156: FR 4572, Jan. 30, 1998; 73 FR 34859, June 19,
p.000156: 2008; 76 FR 31470, June 1, 2011; 79 FR 68115,
p.000156: Nov. 14, 2014]
p.000156:
p.000156: § 814.46 Withdrawal of approval of a PMA.
p.000156: (a) FDA may issue an order with- drawing approval of a PMA if, from any
p.000156:
p.000156: information available to the agency, FDA determines that:
p.000156: (1) Any of the grounds under section 515(e)(1) (A)–(G) of the act applies.
p.000156: (2) Any postapproval requirement im- posed by the PMA approval order or by regulation has not been met.
p.000156: (3) A nonclinical laboratory study that is described in the PMA and that is essential to show that
p.000156: the device is safe for use under the conditions pre- scribed, recommended, or suggested in its proposed
p.000156: labeling, was not con- ducted in compliance with the good laboratory practice regulations in part
p.000156: 58 and no reason for the noncompliance is provided or, if it is, the differences between the practices
p.000156: used in con- ducting the study and the good labora- tory practice regulations do not sup- port the validity of
p.000156: the study.
p.000156: (4) Any clinical investigation involv-
p.000156: ing human subjects described in the PMA, subject to the institutional re- view board regulations in part
p.000156: 56 or in- formed consent regulations in part 50, was not conducted in compliance with those regulations
p.000156: such that the rights or safety of human subjects were not adequately protected.
p.000156: (b)(1) FDA may seek advice on sci- entific matters from any appropriate FDA advisory committee in
p.000156: deciding whether to withdraw approval of a PMA.
p.000156: (2) FDA may use information other than that submitted by the applicant in deciding whether to
p.000156: withdraw ap- proval of a PMA.
p.000156: (c) Before issuing an order with- drawing approval of a PMA, FDA will issue the holder of the
p.000156: approved appli- cation a notice of opportunity for an informal hearing under part 16.
p.000156: (d) If the applicant does not request a hearing or if after the part 16 hearing is held the agency decides
p.000156: to proceed with the withdrawal, FDA will issue to the holder of the approved application an order withdrawing
p.000156: approval of the application. The order will be issued under § 814.17, will state each ground for
p.000156: withdrawing approval, and will in- clude a notice of an opportunity for ad- ministrative review under
p.000156: section 515(e)(2) of the act.
p.000156: (e) FDA will give the public notice of an order withdrawing approval of a PMA. The notice will be
p.000156: published in
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: § 814.47
p.000157: the FEDERAL REGISTER and will state that a detailed summary of informa- tion respecting the safety
p.000157: and effec- tiveness of the device, including infor- mation about any adverse effects of the device on health, ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
ageAge
authorityRelationship to Authority
childrenChild
drugDrug Usage
emergencyPublic Emergency
emergency situationpatients in emergency situations
employeesemployees
freedomXofXinformationAccess to information
homeProperty Ownership
illnessPhysically Disabled
minorYouth/Minors
nationstateless persons
nativeIndigenous
neonatesFetus/Neonate
officerPolice Officer
opinionphilosophical differences/differences of opinion
orphanorphan
restrictedIncarcerated
singleMarital Status
threatThreat of Stigma

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers

Trigger Words

consent

harm

protect

protection

risk

welfare


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIndigenousnative3
Politicalstateless personsnation1
HealthDrug Usagedrug33
HealthPhysically Disabledillness2
Healthpatients in emergency situationsemergency situation0
SocialAccess to Social Goodsaccess3
SocialAccess to informationfreedomXofXinformation0
SocialAgeage2
SocialChildchildren1
SocialFetus/Neonateneonates2
SocialIncarceratedrestricted1
SocialMarital Statussingle2
SocialPolice Officerofficer1
SocialProperty Ownershiphome2
SocialThreat of Stigmathreat1
SocialYouth/Minorsminor2
Socialemployeesemployees1
Socialorphanorphan3
Socialphilosophical differences/differences of opinionopinion3
General/OtherPublic Emergencyemergency2
General/OtherRelationship to Authorityauthority4