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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| 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
Political / Indigenous
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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
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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,
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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.
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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.
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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
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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
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Political / stateless persons
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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
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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
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Health / Drug Usage
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p.000143: Food and Drug Administration, HHS § 814.2
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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
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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: Food and Drug Administration, HHS § 814.9
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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
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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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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.
...
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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
...
Social / Child
Searching for indicator children:
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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
Searching for indicator neonates:
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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
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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
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Social / Police 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
Searching for indicator threat:
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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:
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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:
(return to top)
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
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| children | Child |
| drug | Drug Usage |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| freedomXofXinformation | Access to information |
| home | Property Ownership |
| illness | Physically Disabled |
| minor | Youth/Minors |
| nation | stateless persons |
| native | Indigenous |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| restricted | Incarcerated |
| single | Marital Status |
| threat | Threat of Stigma |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input