0A4F4F9BD490A749D5437F821CF06DF1
21 CFR 812
https://www.govinfo.gov/content/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-part812.pdf
http://leaux.net/URLS/ConvertAPI Text Files/80EFA3603CBEDADAD513DD3BC97B1740.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
Searching for indicator native:
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p.000105: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000105: FR 8956, Jan. 27, 1981; 48 FR 15622, Apr. 12,
p.000105: 1983]
p.000105:
p.000105: § 812.5 Labeling of investigational de- vices.
p.000105: (a) Contents. An investigational de- vice or its immediate package shall bear a label with the
p.000105: following infor- mation: the name and place of business of the manufacturer, packer, or dis- tributor (in
p.000105: accordance with § 801.1), the quantity of contents, if appro- priate, and the following
p.000105: statement: ‘‘CAUTION—Investigational device. Limited by Federal (or United States) law to investigational
p.000105: use.’’ The label or other labeling shall describe all rel- evant contraindications, hazards, ad- verse
p.000105: effects, interfering substances or devices, warnings, and precautions.
p.000105: (b) Prohibitions. The labeling of an in- vestigational device shall not bear any statement that is false or
p.000105: misleading in any particular and shall not represent that the device is safe or effective for the purposes
p.000105: for which it is being in- vestigated.
p.000105: (c) Animal research. An investiga- tional device shipped solely for re- search on or with
p.000105: laboratory animals shall bear on its label the following statement: ‘‘CAUTION—Device for in-
p.000105: vestigational use in laboratory animals or other tests that do not involve human subjects.’’
p.000105: (d) The appropriate FDA Center Di- rector, according to the procedures set forth in § 801.128 or § 809.11 of
p.000105: this chap- ter, may grant an exception or alter- native to the provisions in paragraphs
p.000105: (a) and (c) of this section, to the extent that these provisions are not explicitly required by statute, for
p.000105: specified lots, batches, or other units of a device that
p.000105: 21 CFR Ch. I (4–1–11 Edition)
p.000105: are or will be included in the Strategic National Stockpile.
p.000105: [45 FR 3751, Jan. 18, 1980, as amended at 45
p.000105: FR 58842, Sept. 5, 1980; 72 FR 73602, Dec. 28,
p.000105: 2007]
p.000105:
p.000105: § 812.7 Prohibition of promotion and other practices.
p.000105: A sponsor, investigator, or any per- son acting for or on behalf of a sponsor or investigator shall not:
p.000105: (a) Promote or test market an inves- tigational device, until after FDA has approved the device for
p.000105: commercial distribution.
p.000105: (b) Commercialize an investigational device by charging the subjects or in- vestigators for a device a
p.000105: price larger than that necessary to recover costs of manufacture, research, development, and handling.
p.000105: (c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class
p.000105: III device that premarket approval cannot be jus- tified or in the case of a class II device that it will not
p.000105: comply with an appli- cable performance standard or an amendment to that standard, the spon- sor shall
p.000105: promptly terminate the inves- tigation.
p.000105: (d) Represent that an investigational
p.000105: device is safe or effective for the pur- poses for which it is being investigated.
p.000105: § 812.10 Waivers.
p.000105: (a) Request. A sponsor may request FDA to waive any requirement of this part. A waiver request, with
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Political / stateless persons
Searching for indicator nation:
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p.000102: § 810.18
p.000102: shall include a copy of the most cur- rent status report submitted to the agency under § 810.16. A
p.000102: request for ter- mination of a recall order shall include a description of the disposition of the recalled
p.000102: device.
p.000102: (b) FDA may terminate a cease dis- tribution and notification order issued under § 810.10 or a
p.000102: mandatory recall order issued under § 810.13 when the agency determines that the person named
p.000102: in the order:
p.000102: (1) Has taken all reasonable efforts to ensure and to verify that all health professionals, device
p.000102: user facilities, consignees, and, where appropriate, in- dividuals have been notified of the cease
p.000102: distribution and notification order, and to verify that they have been instructed to cease use
p.000102: of the de- vice and to take other appropriate ac- tion; or
p.000102: (2) Has removed the device from the market or has corrected the device so that use of the device would
p.000102: not cause serious, adverse health consequences or death.
p.000102: (c) FDA will provide written notifica- tion to the person named in the order when a request for
p.000102: termination of a cease distribution and notification order or a mandatory recall order has been
p.000102: granted or denied. FDA will re- spond to a written request for termi- nation of a cease distribution and
p.000102: noti- fication or recall order within 30 work- ing days of its receipt.
p.000102: § 810.18 Public notice.
p.000102: The agency will make available to the public in the weekly FDA Enforce- ment Report a descriptive
p.000102: listing of each new mandatory recall issued under § 810.13. The agency will delay public
p.000102: notification of orders when the agency determines that such notifica- tion may cause unnecessary and harm- ful
p.000102: anxiety in individuals and that ini- tial consultation between individuals and their health professionals
p.000102: is essen- tial.
p.000102:
p.000102: PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
p.000102: Subpart A—General Provisions
p.000102: Sec.
p.000102: 812.1 Scope.
p.000102:
p.000102: 21 CFR Ch. I (4–1–11 Edition)
p.000102: 812.2 Applicability.
p.000102: 812.3 Definitions.
p.000102: 812.5 Labeling of investigational devices.
p.000102: 812.7 Prohibition of promotion and other practices.
p.000102: 812.10 Waivers.
p.000102: 812.18 Import and export requirements.
p.000102: 812.19 Address for IDE correspondence.
p.000102:
p.000102: Subpart B—Application and Administrative Action
p.000102: 812.20 Application.
p.000102: 812.25 Investigational plan.
p.000102: 812.27 Report of prior investigations.
p.000102: 812.30 FDA action on applications.
p.000102: 812.35 Supplemental applications.
p.000102: 812.36 Treatment use of an investigational device.
p.000102: 812.38 Confidentiality of data and informa- tion.
p.000102:
p.000102: Subpart C—Responsibilities of Sponsors
p.000102: 812.40 General responsibilities of sponsors.
p.000102: 812.42 FDA and IRB approval.
p.000102: 812.43 Selecting investigators and monitors.
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p.000107:
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p.000107: § 812.25
p.000107: found an IRB’s review inadequate, or if FDA requests them.
p.000107: (3) A description of the methods, fa- cilities, and controls used for the man- ufacture, processing, packing,
p.000107: storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally
p.000107: familiar with good manufacturing practices can make a knowledgeable judgment about the quality
p.000107: control used in the manufac- ture of the device.
p.000107: (4) An example of the agreements to be entered into by all investigators to comply with investigator
p.000107: obligations under this part, and a list of the names and addresses of all investigators who have signed the
p.000107: agreement.
p.000107: (5) A certification that all investiga- tors who will participate in the inves- tigation have signed
p.000107: the agreement, that the list of investigators includes all the investigators participating in the
p.000107: investigation, and that no inves- tigators will be added to the investiga- tion until they have signed the
p.000107: agree- ment.
p.000107: (6) A list of the name, address, and chairperson of each IRB that has been or will be asked to review
p.000107: the inves- tigation and a certification of the ac- tion concerning the investigation taken by each
p.000107: such IRB.
p.000107: (7) The name and address of any in- stitution at which a part of the inves- tigation may be conducted
p.000107: that has not been identified in accordance with paragraph (b)(6) of this section.
p.000107: (8) If the device is to be sold, the amount to be charged and an expla- nation of why sale does not
p.000107: constitute commercialization of the device.
p.000107: (9) A claim for categorical exclusion under § 25.30 or § 25.34 or an environ- mental assessment under §
p.000107: 25.40.
p.000107: (10) Copies of all labeling for the de- vice.
p.000107: (11) Copies of all forms and informa- tional materials to be provided to sub- jects to obtain informed
p.000107: consent.
p.000107: (12) Any other relevant information FDA requests for review of the applica- tion.
p.000107: (c) Additional information. FDA may request additional information con- cerning an investigation or
p.000107: revision in the investigational plan. The sponsor may treat such a request as a dis- approval of
p.000107: the application for pur-
p.000107: 21 CFR Ch. I (4–1–11 Edition)
p.000107: poses of requesting a hearing under part 16.
p.000107: (d) Information previously submitted. Information previously submitted to the Center for Devices
p.000107: and Radio- logical Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and
p.000107: Research, as applicable, in accordance with this chapter ordinarily need not be resub- mitted, but
p.000107: may be incorporated by reference.
p.000107: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000107: FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26,
p.000107: 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530,
p.000107: Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR
p.000107: 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008]
p.000107:
p.000107: § 812.25 Investigational plan.
p.000107: The investigational plan shall in- clude, in the following order:
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p.000114: [45 FR 3751, Jan. 18, 1980, as amended at 63
p.000114: FR 5253, Feb. 2, 1998]
p.000114: § 812.45 Informing investigators.
p.000114: A sponsor shall supply all investiga- tors participating in the investigation with copies of the
p.000114: investigational plan and the report of prior investigations of the device.
p.000114: § 812.46 Monitoring investigations.
p.000114: (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the
p.000114: signed agree- ment, the investigational plan, the re- quirements of this part or other appli- cable FDA
p.000114: regulations, or any condi- tions of approval imposed by the re- viewing IRB or FDA shall promptly ei- ther
p.000114: secure compliance, or discontinue shipments of the device to the investi- gator and terminate the
p.000114: investigator’s participation in the investigation. A sponsor shall also require such an in- vestigator
p.000114: to dispose of or return the device, unless this action would jeop- ardize the rights, safety, or welfare of a
p.000114: subject.
p.000114: (b) Unanticipated adverse device effects.
p.000114: (1) A sponsor shall immediately con- duct an evaluation of any unantici- pated adverse device effect.
p.000114: (2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to
p.000114: sub- jects shall terminate all investigations or parts of investigations presenting that risk as soon as
p.000114: possible. Termi- nation shall occur not later than 5 working days after the sponsor makes this
p.000114: determination and not later than
p.000114:
p.000114: 15 working days after the sponsor first received notice of the effect.
p.000114: (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not
p.000114: resume a termi- nated investigation without IRB and FDA approval. If the device is not a significant
p.000114: risk device, a sponsor may not resume a terminated investigation without IRB approval and, if the inves-
p.000114: tigation was terminated under para- graph (b)(2) of this section, FDA ap- proval.
p.000114: § 812.47 Emergency research under
p.000114: § 50.24 of this chapter.
p.000114: (a) The sponsor shall monitor the progress of all investigations involving an exception from informed
p.000114: consent under § 50.24 of this chapter. When the sponsor receives from the IRB informa- tion concerning the
p.000114: public disclosures under § 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter, the sponsor shall prompt- ly
p.000114: submit to the IDE file and to Docket Number 95S–0158 in the Division of Dockets Management (HFA–305), Food
p.000114: and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, copies of the information that
p.000114: was dis- closed, identified by the IDE number.
p.000114: (b) The sponsor also shall monitor such investigations to determine when an IRB determines that it
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Health / Cognitive Impairment
Searching for indicator impairment:
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p.000104: or inten- tion: (1) Penetrate or pierce the skin or mucous membranes of the body, the oc- ular cavity, or the urethra,
p.000104: or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the
p.000104: pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood
p.000104: sampling that involves simple venipuncture is considered noninvasive, and the use of surplus
p.000104: samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes
p.000104: is also considered noninvasive.
p.000104: (l) Person includes any individual,
p.000104: partnership, corporation, association, scientific or academic establishment, Government agency or
p.000104: organizational unit of a Government agency, and any other legal entity.
p.000104:
p.000104: (m) Significant risk device means an investigational device that:
p.000104: (1) Is intended as an implant and pre- sents a potential for serious risk to the health, safety, or welfare of a
p.000104: subject;
p.000104: (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a
p.000104: potential for serious risk to the health, safety, or welfare of a subject;
p.000104: (3) Is for a use of substantial impor- tance in diagnosing, curing, miti- gating, or treating
p.000104: disease, or other- wise preventing impairment of human health and presents a potential for se- rious risk
p.000104: to the health, safety, or wel- fare of a subject; or
p.000104: (4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
p.000104: (n) Sponsor means a person who initi- ates, but who does not actually con- duct, the investigation, that is,
p.000104: the in- vestigational device is administered, dispensed, or used under the immediate direction of another
p.000104: individual. A per- son other than an individual that uses one or more of its own employees to conduct
p.000104: an investigation that it has initiated is a sponsor, not a sponsor-in- vestigator, and the employees are
p.000104: in- vestigators.
p.000104: (o) Sponsor-investigator means an indi- vidual who both initiates and actually conducts, alone or with others,
p.000104: an in- vestigation, that is, under whose im-
p.000104: mediate direction the investigational device is administered, dispensed, or used. The term does not
p.000104: include any person other than an individual. The obligations of a sponsor-investigator under this part
p.000104: include those of an in- vestigator and those of a sponsor.
p.000104: (p) Subject means a human who par- ticipates in an investigation, either as an individual on whom or
p.000104: on whose specimen an investigational device is used or as a control. A subject may be in normal
p.000104: health or may have a med- ical condition or disease.
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Health / Drug Usage
Searching for indicator drug:
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p.000102: 812.35 Supplemental applications.
p.000102: 812.36 Treatment use of an investigational device.
p.000102: 812.38 Confidentiality of data and informa- tion.
p.000102:
p.000102: Subpart C—Responsibilities of Sponsors
p.000102: 812.40 General responsibilities of sponsors.
p.000102: 812.42 FDA and IRB approval.
p.000102: 812.43 Selecting investigators and monitors.
p.000102: 812.45 Informing investigators.
p.000102: 812.46 Monitoring investigations.
p.000102: 812.47 Emergency research under § 50.24 of this chapter.
p.000102:
p.000102: Subpart D—IRB Review and Approval
p.000102: 812.60 IRB composition, duties, and func- tions.
p.000102: 812.62 IRB approval.
p.000102: 812.64 IRB’s continuing review.
p.000102: 812.65 [Reserved]
p.000102: 812.66 Significant risk device determina- tions.
p.000102:
p.000102: Subpart E—Responsibilities of Investigators
p.000102: 812.100 General responsibilities of investiga- tors.
p.000102: 812.110 Specific responsibilities of investiga- tors.
p.000102: 812.119 Disqualification of a clinical investi- gator.
p.000102:
p.000102: Subpart F [Reserved]
p.000102: Subpart G—Records and Reports
p.000102: 812.140 Records.
p.000102: 812.145 Inspections.
p.000102: 812.150 Reports.
p.000102: AUTHORITY: 21 U.S.C. 331, 351, 352, 353, 355,
p.000102: 360, 360c–360f, 360h–360j, 371, 372, 374, 379e, 381,
p.000102: 382, 383; 42 U.S.C. 216, 241, 262, 263b–263n.
p.000102: SOURCE: 45 FR 3751, Jan. 18, 1980, unless
p.000102: otherwise noted.
p.000102: 102
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p.000102: Food and Drug Administration, HHS § 812.2
p.000102:
p.000102: Subpart A—General Provisions
p.000102: § 812.1 Scope.
p.000102: (a) The purpose of this part is to en- courage, to the extent consistent with the protection of
p.000102: public health and safety and with ethical standards, the discovery and development of useful devices
p.000102: intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pur- suit of
p.000102: this purpose. This part provides procedures for the conduct of clinical investigations of devices. An approved
p.000102: investigational device exemption (IDE) permits a device that otherwise would be required to comply with a
p.000102: perform- ance standard or to have premarket ap- proval to be shipped lawfully for the purpose of conducting
p.000102: investigations of that device. An IDE approved under
p.000102: § 812.30 or considered approved under
p.000102: § 812.2(b) exempts a device from the re- quirements of the following sections of the Federal Food, Drug, and
p.000102: Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act,
p.000102: registration, listing, and premarket notification under section 510, performance standards under sec- tion
p.000102: 514, premarket approval under sec- tion 515, a banned device regulation under section 516, records and
p.000102: reports under section 519, restricted device re- quirements under section 520(e), good manufacturing
p.000102: practice requirements under section 520(f) except for the re- quirements found in § 820.30, if applica-
p.000102: ble (unless the sponsor states an inten- tion to comply with these require- ments under §
p.000102: 812.20(b)(3) or
p.000102: § 812.140(b)(4)(v)) and color additive re-
p.000102: quirements under section 721.
p.000102: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000102: title 21, unless otherwise noted.
p.000102: [45 FR 3751, Jan. 18, 1980, as amended at 59
p.000102: FR 14366, Mar. 28, 1994; 61 FR 52654, Oct. 7,
p.000102: 1996]
p.000102: § 812.2 Applicability.
p.000102: (a) General. This part applies to all clinical investigations of devices to de- termine safety and
p.000102: effectiveness, ex- cept as provided in paragraph (c) of this section.
p.000102: (b) Abbreviated requirements. The fol- lowing categories of investigations are
p.000102:
p.000102: considered to have approved applica- tions for IDE’s, unless FDA has noti- fied a sponsor under §
p.000102: 812.20(a) that ap- proval of an application is required:
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p.000103: (ii) Does not require an invasive sam- pling procedure that presents signifi- cant risk,
p.000103: (iii) Does not by design or intention introduce energy into a subject, and
p.000103: (iv) Is not used as a diagnostic proce- dure without confirmation of the diag- nosis by another, medically
p.000103: established diagnostic product or procedure.
p.000103: (4) A device undergoing consumer preference testing, testing of a modi- fication, or testing of a
p.000103: combination of two or more devices in commercial dis- tribution, if the testing is not for the purpose of
p.000103: determining safety or effec- tiveness and does not put subjects at risk.
p.000103: (5) A device intended solely for vet- erinary use.
p.000103: (6) A device shipped solely for re- search on or with laboratory animals and labeled in
p.000103: accordance with
p.000103: § 812.5(c).
p.000103: (7) A custom device as defined in
p.000103: § 812.3(b), unless the device is being used to determine safety or effective- ness for commercial
p.000103: distribution.
p.000103: (d) Limit on certain exemptions. In the case of class II or class III device de- scribed in paragraph
p.000103: (c)(1) or (2) of this section, this part applies beginning on the date stipulated in an FDA regula- tion or
p.000103: order that calls for the submis- sion of premarket approval applica- tions for an unapproved class III
p.000103: de- vice, or establishes a performance standard for a class II device.
p.000103: (e) Investigations subject to IND’s. A sponsor that, on July 16, 1980, has an effective
p.000103: investigational new drug ap- plication (IND) for an investigation of a device shall continue to comply with the
p.000103: requirements of part 312 until 90 days after that date. To continue the investigation after that date, a
p.000103: sponsor shall comply with paragraph (b)(1) of this section, if the device is not a sig- nificant risk
p.000103: device, or shall have ob- tained FDA approval under § 812.30 of
p.000103: 21 CFR Ch. I (4–1–11 Edition)
p.000103: an IDE application for the investiga- tion of the device.
p.000103: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000103: FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27,
p.000103: 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan,
p.000103: 29, 1997; 62 FR 12096, Mar. 14, 1997]
p.000103: § 812.3 Definitions.
p.000103: (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201– 901, 52 Stat. 1040 et seq., as
p.000103: amended (21
p.000103: U.S.C. 301–392)).
p.000103: (b) Custom device means a device that:
p.000103: (1) Necessarily deviates from devices generally available or from an applica- ble performance standard or premarket
p.000103: approval requirement in order to com- ply with the order of an individual phy- sician or dentist;
p.000103: (2) Is not generally available to, or generally used by, other physicians or dentists;
p.000103: (3) Is not generally available in fin- ished form for purchase or for dis- pensing upon prescription;
p.000103: (4) Is not offered for commercial dis- tribution through labeling or adver- tising; and
p.000103: (5) Is intended for use by an indi- vidual patient named in the order of a physician or dentist,
p.000103: and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician
p.000103: or dentist in the course of professional practice.
p.000103: (c) FDA means the Food and Drug Administration.
p.000103: (d) Implant means a device that is placed into a surgically or naturally formed cavity of the
p.000103: human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect
p.000103: public health, determine that devices placed in subjects for shorter periods are also ‘‘implants’’ for
p.000103: purposes of this part.
p.000103: (e) Institution means a person, other than an individual, who engages in the conduct of research on
p.000103: subjects or in the delivery of medical services to indi- viduals as a primary activity or as an adjunct to
p.000103: providing residential or cus- todial care to humans. The term in- cludes, for example, a hospital, retire-
p.000103: ment home, confinement facility, aca- demic establishment, and device manu- facturer. The term has the same mean-
p.000103: ing as ‘‘facility’’ in section 520(g) of the act.
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p.000104:
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p.000104:
p.000104:
p.000104: Food and Drug Administration, HHS § 812.3
p.000104:
p.000104:
p.000104: (f) Institutional revie board (IRB) means any board, committee, or other group formally designated
p.000104: by an insti- tution to review biomedical research involving subjects and established, op- erated, and
p.000104: functioning in conformance with part 56. The term has the same meaning as ‘‘institutional review com-
p.000104: mittee’’ in section 520(g) of the act.
p.000104: (g) Investigational device means a de- vice, including a transitional device, that is the object of an
p.000104: investigation.
p.000104: (h) Investigation means a clinical in- vestigation or research involving one or more subjects to determine the
p.000104: safe- ty or effectiveness of a device.
p.000104: (i) Investigator means an individual who actually conducts a clinical inves- tigation, i.e., under whose
p.000104: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject, or,
p.000104: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000104: team.
p.000104: (j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research
p.000104: organiza- tion to oversee the progress of an in- vestigation. The monitor may be an employee of a
p.000104: sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research orga-
p.000104: nization. Monitor, when used as a verb, means to oversee an investigation.
p.000104: (k) Noninvasive, when applied to a di- agnostic device or procedure, means one that does not by design
...
p.000104: (n) Sponsor means a person who initi- ates, but who does not actually con- duct, the investigation, that is,
p.000104: the in- vestigational device is administered, dispensed, or used under the immediate direction of another
p.000104: individual. A per- son other than an individual that uses one or more of its own employees to conduct
p.000104: an investigation that it has initiated is a sponsor, not a sponsor-in- vestigator, and the employees are
p.000104: in- vestigators.
p.000104: (o) Sponsor-investigator means an indi- vidual who both initiates and actually conducts, alone or with others,
p.000104: an in- vestigation, that is, under whose im-
p.000104: mediate direction the investigational device is administered, dispensed, or used. The term does not
p.000104: include any person other than an individual. The obligations of a sponsor-investigator under this part
p.000104: include those of an in- vestigator and those of a sponsor.
p.000104: (p) Subject means a human who par- ticipates in an investigation, either as an individual on whom or
p.000104: on whose specimen an investigational device is used or as a control. A subject may be in normal
p.000104: health or may have a med- ical condition or disease.
p.000104: (q) Termination means a discontinu- ance, by sponsor or by withdrawal of IRB or FDA approval, of an
p.000104: investiga- tion before completion.
p.000104: (r) Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA
p.000104: considered to be a new drug or an antibiotic drug before May 28, 1976.
p.000105: 105
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: § 812.5
p.000105: (s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any
p.000105: life-threatening problem or death caused by, or associ- ated with, a device, if that effect, prob- lem, or
p.000105: death was not previously iden- tified in nature, severity, or degree of incidence in the investigational plan
p.000105: or application (including a supplementary plan or application), or any other un- anticipated serious problem
p.000105: associated with a device that relates to the rights, safety, or welfare of subjects.
p.000105: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000105: FR 8956, Jan. 27, 1981; 48 FR 15622, Apr. 12,
p.000105: 1983]
p.000105:
p.000105: § 812.5 Labeling of investigational de- vices.
p.000105: (a) Contents. An investigational de- vice or its immediate package shall bear a label with the
p.000105: following infor- mation: the name and place of business of the manufacturer, packer, or dis- tributor (in
p.000105: accordance with § 801.1), the quantity of contents, if appro- priate, and the following
p.000105: statement: ‘‘CAUTION—Investigational device. Limited by Federal (or United States) law to investigational
p.000105: use.’’ The label or other labeling shall describe all rel- evant contraindications, hazards, ad- verse
p.000105: effects, interfering substances or devices, warnings, and precautions.
p.000105: (b) Prohibitions. The labeling of an in- vestigational device shall not bear any statement that is false or
...
p.000105: price larger than that necessary to recover costs of manufacture, research, development, and handling.
p.000105: (c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class
p.000105: III device that premarket approval cannot be jus- tified or in the case of a class II device that it will not
p.000105: comply with an appli- cable performance standard or an amendment to that standard, the spon- sor shall
p.000105: promptly terminate the inves- tigation.
p.000105: (d) Represent that an investigational
p.000105: device is safe or effective for the pur- poses for which it is being investigated.
p.000105: § 812.10 Waivers.
p.000105: (a) Request. A sponsor may request FDA to waive any requirement of this part. A waiver request, with
p.000105: supporting documentation, may be submitted sep- arately or as part of an application to the address in §
p.000105: 812.19.
p.000105: (b) FDA action. FDA may by letter grant a waiver of any requirement that FDA finds is not required by the
p.000105: act and is unnecessary to protect the rights, safety, or welfare of human sub- jects.
p.000105: (c) Effect of request. Any requirement shall continue to apply unless and until FDA waives it.
p.000105: § 812.18 Import and export require- ments.
p.000105: (a) Imports. In addition to complying with other requirements of this part, a person who imports or offers for
p.000105: impor- tation an investigational device sub- ject to this part shall be the agent of
p.000106: 106
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: Food and Drug Administration, HHS § 812.20
p.000106:
p.000106:
p.000106: the foreign exporter with respect to in- vestigations of the device and shall act as the sponsor of the clinical
p.000106: investiga- tion, or ensure that another person acts as the agent of the foreign ex- porter and
p.000106: the sponsor of the investiga- tion.
p.000106: (b) Exports. A person exporting an in- vestigational device subject to this part shall obtain FDA’s prior
p.000106: approval, as required by section 801(e) of the act or comply with section 802 of the act.
p.000106: [45 FR 3751, Jan. 18, 1980, as amended at 62
p.000106: FR 26229, May 13, 1997]
p.000106:
p.000106: § 812.19 Address for IDE correspond- ence.
p.000106: (a) If you are sending an application, supplemental application, report, re- quest for waiver, request for
p.000106: import or export approval, or other correspond- ence relating to matters covered by this part, you
p.000106: must send the submis- sion to the appropriate address as fol- lows:
p.000106: (1) For devices regulated by the Cen- ter for Devices and Radiological Health, send it to
p.000106: Food and Drug Ad- ministration, Center for Devices and Radiological Health, Document Mail Center,
p.000106: 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993–0002.
p.000106: (2) For devices regulated by the Cen- ter for Biologics Evaluation and Re- search, send it to the
p.000106: Document Con- trol Center (HFM–99), Center for Bio- logics Evaluation and Research, Food and Drug
p.000106: Administration, 1401 Rock- ville Pike, suite 200N, Rockville, MD 20852–1448.
p.000106: (3) For devices regulated by the Cen- ter for Drug Evaluation and Research, send it to Central Document
p.000106: Control Room, Center for Drug Evaluation and Research, Food and Drug Administra- tion, 5901–B Ammendale Rd.,
p.000106: Beltsville, MD 20705–1266.
p.000106: (b) You must state on the outside wrapper of each submission what the submission is, for example, an
p.000106: ‘‘IDE ap- plication,’’ a ‘‘supplemental IDE appli- cation,’’ or a ‘‘correspondence con- cerning an
p.000106: IDE (or an IDE applica- tion).’’
p.000106: [71 FR 42048, July 25, 2006, as amended at 75
p.000106: FR 20915, Apr. 22, 2010]
p.000106: Subpart B—Application and Administrative Action
p.000106: § 812.20 Application.
p.000106: (a) Submission. (1) A sponsor shall submit an application to FDA if the sponsor intends to use
p.000106: a significant risk device in an investigation, intends to conduct an investigation that in- volves an
p.000106: exception from informed con- sent under § 50.24 of this chapter, or if FDA notifies the sponsor that an appli-
p.000106: cation is required for an investigation.
p.000106: (2) A sponsor shall not begin an in- vestigation for which FDA’s approval of an application is required
p.000106: until FDA has approved the application.
p.000106: (3) A sponsor shall submit three cop- ies of a signed ‘‘Application for an In- vestigational Device
p.000106: Exemption’’ (IDE application), together with accom- panying materials, by registered mail or by hand
p.000106: to the address in § 812.19. Subsequent correspondence concerning an application or a supplemental appli- cation
p.000106: shall be submitted by registered mail or by hand.
p.000106: (4)(i) A sponsor shall submit a sepa- rate IDE for any clinical investigation involving an exception from
...
p.000107: (6) A list of the name, address, and chairperson of each IRB that has been or will be asked to review
p.000107: the inves- tigation and a certification of the ac- tion concerning the investigation taken by each
p.000107: such IRB.
p.000107: (7) The name and address of any in- stitution at which a part of the inves- tigation may be conducted
p.000107: that has not been identified in accordance with paragraph (b)(6) of this section.
p.000107: (8) If the device is to be sold, the amount to be charged and an expla- nation of why sale does not
p.000107: constitute commercialization of the device.
p.000107: (9) A claim for categorical exclusion under § 25.30 or § 25.34 or an environ- mental assessment under §
p.000107: 25.40.
p.000107: (10) Copies of all labeling for the de- vice.
p.000107: (11) Copies of all forms and informa- tional materials to be provided to sub- jects to obtain informed
p.000107: consent.
p.000107: (12) Any other relevant information FDA requests for review of the applica- tion.
p.000107: (c) Additional information. FDA may request additional information con- cerning an investigation or
p.000107: revision in the investigational plan. The sponsor may treat such a request as a dis- approval of
p.000107: the application for pur-
p.000107: 21 CFR Ch. I (4–1–11 Edition)
p.000107: poses of requesting a hearing under part 16.
p.000107: (d) Information previously submitted. Information previously submitted to the Center for Devices
p.000107: and Radio- logical Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and
p.000107: Research, as applicable, in accordance with this chapter ordinarily need not be resub- mitted, but
p.000107: may be incorporated by reference.
p.000107: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000107: FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26,
p.000107: 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530,
p.000107: Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR
p.000107: 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008]
p.000107:
p.000107: § 812.25 Investigational plan.
p.000107: The investigational plan shall in- clude, in the following order:
p.000107: (a) Purpose. The name and intended use of the device and the objectives and duration of the investigation.
p.000107: (b) Protocol. A written protocol de- scribing the methodology to be used and an analysis of the
p.000107: protocol dem- onstrating that the investigation is scientifically sound.
p.000107: (c) Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by
p.000107: the inves- tigation; the manner in which these risks will be minimized; a justification for the
p.000107: investigation; and a description of the patient population, including the number, age, sex, and condition.
p.000107: (d) Description of device. A description of each important component, ingre- dient, property, and
p.000107: principle of oper- ation of the device and of each antici- pated change in the device during the course
p.000107: of the investigation.
p.000107: (e) Monitoring procedures. The spon- sor’s written procedures for monitoring the investigation and the name and
p.000107: ad- dress of any monitor.
p.000107: (f) Labeling. Copies of all labeling for the device.
p.000107: (g) Consent materials. Copies of all forms and informational materials to be provided to subjects to
p.000107: obtain in- formed consent.
p.000107: (h) IRB information. A list of the names, locations, and chairpersons of all IRB’s that have
p.000107: been or will be asked to review the investigation, and a certification of any action taken by
p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Food and Drug Administration, HHS § 812.30
p.000108:
p.000108:
p.000108: any of those IRB’s with respect to the investigation.
p.000108: (i) Other institutions. The name and address of each institution at which a part of the investigation
p.000108: may be con- ducted that has not been identified in paragraph (h) of this section.
p.000108: (j) Additional records and reports. A de- scription of records and reports that will be maintained on the
p.000108: investigation in addition to those prescribed in sub- part G.
p.000108: § 812.27 Report of prior investigations.
p.000108: (a) General. The report of prior inves- tigations shall include reports of all prior clinical, animal,
p.000108: and laboratory testing of the device and shall be com- prehensive and adequate to justify the proposed
p.000108: investigation.
p.000108: (b) Specific contents. The report also shall include:
p.000108: (1) A bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the
p.000108: safety or effectiveness of the device, copies of all published and unpublished adverse information, and, if
p.000108: requested by an IRB or FDA, copies of other significant publications.
p.000108: (2) A summary of all other unpub- lished information (whether adverse or supportive) in the possession of, or
p.000108: rea- sonably obtainable by, the sponsor that is relevant to an evaluation of the safe- ty or effectiveness of the
p.000108: device.
p.000108: (3) If information on nonclinical lab- oratory studies is provided, a state- ment that all such
p.000108: studies have been conducted in compliance with applica- ble requirements in the good labora- tory practice
...
p.000109: (iii) Definition of credible information.
p.000109: (A) Credible information to support de- velopmental changes in the device (in- cluding manufacturing
p.000109: changes) in- cludes data generated under the design control procedures of § 820.30, pre- clinical/animal
p.000109: testing, peer reviewed published literature, or other reliable information such as clinical informa- tion
p.000109: gathered during a trial or mar- keting.
p.000109: (B) Credible information to support changes to clinical protocols is defined as the sponsor’s documentation
p.000109: sup- porting the conclusion that a change does not have a significant impact on the study design or
p.000109: planned statistical analysis, and that the change does not affect the rights, safety, or welfare of the
p.000109: subjects. Documentation shall in- clude information such as peer re- viewed published literature,
p.000109: the rec- ommendation of the clinical investi- gator(s), and/or the data gathered dur- ing the clinical
p.000109: trial or marketing.
p.000109: (iv) Notice of IDE change. Changes meeting the criteria in paragraphs (a)(3)(i) and
p.000109: (a)(3)(ii) of this section that are supported by credible informa-
p.000109: tion as defined in paragraph (a)(3)(iii) of this section may be made without prior FDA approval if the
p.000109: sponsor sub- mits a notice of the change to the IDE not later than 5-working days after making the
p.000109: change. Changes to devices
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: Food and Drug Administration, HHS § 812.36
p.000110:
p.000110:
p.000110: are deemed to occur on the date the de- vice, manufactured incorporating the design or manufacturing change, is
p.000110: dis- tributed to the investigator(s). Changes to a clinical protocol are deemed to occur when a clinical
p.000110: investigator is notified by the sponsor that the change should be implemented in the protocol or, for
p.000110: sponsor-investigator studies, when a sponsor-investigator incor- porates the change in the
p.000110: protocol. Such notices shall be identified as a ‘‘notice of IDE change.’’
p.000110: (A) For a developmental or manufac-
p.000110: turing change to the device, the notice shall include a summary of the rel- evant information gathered
p.000110: during the course of the investigation upon which the change was based; a description of the change to
p.000110: the device or manufac- turing process (cross-referenced to the appropriate sections of the original de- vice
p.000110: description or manufacturing process); and, if design controls were used to assess the change, a
p.000110: statement that no new risks were identified by appropriate risk analysis and that the verification and
p.000110: validation testing, as appropriate, demonstrated that the de- sign outputs met the design input re-
p.000110: quirements. If another method of as- sessment was used, the notice shall in- clude a summary of the
p.000110: information which served as the credible informa- tion supporting the change.
p.000110: (B) For a protocol change, the notice
...
p.000111: (viii) A statement of the sponsor’s commitment to meet all applicable re- sponsibilities under this
p.000111: part and part 56 of this chapter and to ensure compli- ance of all participating investigators with the
p.000111: informed consent require- ments of part 50 of this chapter;
p.000111: (ix) An example of the agreement to be signed by all investigators partici- pating in the treatment IDE
p.000111: and cer- tification that no investigator will be added to the treatment IDE before the agreement is signed;
p.000111: and
p.000111: (x) If the device is to be sold, the price to be charged and a statement in- dicating that the price is
p.000111: based on manufacturing and handling costs only.
p.000111: (2) A licensed practitioner who re- ceives an investigational device for treatment use under a
p.000111: treatment IDE is an ‘‘investigator’’ under the IDE and is responsible for meeting all applica- ble investigator
p.000111: responsibilities under this part and parts 50 and 56 of this chapter.
p.000111: (d) FDA action on treatment IDE appli- cations—(1) Approval of treatment IDE’s. Treatment use may begin 30
p.000111: days after FDA receives the treatment IDE sub- mission at the address specified in
p.000111: § 812.19, unless FDA notifies the sponsor in writing earlier than the 30 days that the treatment use may or
p.000111: may not begin. FDA may approve the treatment use as proposed or approve it with modifications.
p.000112: 112
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112: Food and Drug Administration, HHS § 812.38
p.000112:
p.000112:
p.000112: (2) Disapproval or ithdra al of ap- proval of treatment IDE’s. FDA may dis- approve or withdraw
p.000112: approval of a treatment IDE if:
p.000112: (i) The criteria specified in § 812.36(b) are not met or the treatment IDE does not contain the information
p.000112: required in § 812.36(c);
p.000112: (ii) FDA determines that any of the grounds for disapproval or withdrawal of approval listed in
p.000112: § 812.30(b)(1) through (b)(5) apply;
p.000112: (iii) The device is intended for a seri- ous disease or condition and there is insufficient evidence of safety
p.000112: and ef- fectiveness to support such use;
p.000112: (iv) The device is intended for an im- mediately life-threatening disease or condition and the available
p.000112: scientific evidence, taken as a whole, fails to pro- vide a reasonable basis for concluding that the device:
p.000112: (A) May be effective for its intended use in its intended population; or
p.000112: (B) Would not expose the patients to whom the device is to be administered to an unreasonable and
p.000112: significant ad- ditional risk of illness or injury;
p.000112: (v) There is reasonable evidence that the treatment use is impeding enroll- ment in, or otherwise
p.000112: interfering with the conduct or completion of, a con- trolled investigation of the same or an- other
p.000112: investigational device;
p.000112: (vi) The device has received mar- keting approval/clearance or a com- parable device or
...
p.000112: safety and effectiveness of the device that was the basis for an order approving, dis- approving, or
p.000112: withdrawing approval of an application for an IDE for a banned device. The summary shall include in-
p.000112: formation on any adverse effect on health caused by the device.
p.000112: (2) If a device is a banned device or if the existence of an IDE has been pub- licly disclosed or
p.000112: acknowledged, data or information contained in the file is
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 812.40
p.000113: not available for public disclosure be- fore approval of an application for pre- market approval or the
p.000113: effective date of a notice of completion of a product development protocol except as pro- vided in
p.000113: this section. FDA may, in its discretion, disclose a summary of se- lected portions of the safety and
p.000113: effec- tiveness data, that is, clinical, animal, or laboratory studies and tests of the device, for
p.000113: public consideration of a specific pending issue.
p.000113: (3) If the existence of an IDE file has
p.000113: not been publicly disclosed or acknowl- edged, no data or information in the file are available for public
p.000113: disclosure except as provided in paragraphs (b)(1) and (c) of this section.
p.000113: (4) Notwithstanding paragraph (b)(2) of this section, FDA will make avail- able to the public, upon request,
p.000113: the in- formation in the IDE that was required to be filed in Docket Number 95S–0158 in the Division of Dockets
p.000113: Management (HFA–305), Food and Drug Administra- tion, 5630 Fishers Lane, rm. 1061, Rock- ville, MD 20852, for
p.000113: investigations in- volving an exception from informed consent under § 50.24 of this chapter. Persons
p.000113: wishing to request this infor- mation shall submit a request under the Freedom of Information Act.
p.000113: (c) Reports of adverse effects. Upon re-
p.000113: quest or on its own initiative, FDA shall disclose to an individual on whom an investigational device has
p.000113: been used a copy of a report of adverse device ef- fects relating to that use.
p.000113: (d) Other rules. Except as otherwise provided in this section, the avail- ability for public
p.000113: disclosure of data and information in an IDE file shall be han- dled in accordance with § 814.9.
p.000113: [45 FR 3751, Jan. 18, 1980, as amended at 53
p.000113: FR 11253, Apr. 6, 1988; 61 FR 51531, Oct. 2,
p.000113: 1996]
p.000113:
p.000113: Subpart C—Responsibilities of Sponsors
p.000113: § 812.40 General responsibilities of sponsors.
p.000113: Sponsors are responsible for selecting qualified investigators and providing them with the information they
p.000113: need to conduct the investigation properly, ensuring proper monitoring of the in- vestigation, ensuring that
p.000113: IRB review and approval are obtained, submitting
p.000113: 21 CFR Ch. I (4–1–11 Edition)
p.000113: an IDE application to FDA, and ensur- ing that any reviewing IRB and FDA are promptly informed of
p.000113: significant new information about an investiga- tion. Additional responsibilities of sponsors are
p.000113: described in subparts B and G.
p.000113: § 812.42 FDA and IRB approval.
...
p.000113:
p.000113: § 812.43 Selecting investigators and monitors.
p.000113: (a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to
p.000113: investigate the device.
p.000113: (b) Control of device. A sponsor shall ship investigational devices only to qualified investigators
p.000113: participating in the investigation.
p.000113: (c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed
p.000113: agreement that includes:
p.000113: (1) The investigator’s curriculum vitae.
p.000113: (2) Where applicable, a statement of the investigator’s relevant experience, including the dates, location,
p.000113: extent, and type of experience.
p.000113: (3) If the investigator was involved in an investigation or other research that was terminated, an explanation of
p.000113: the circumstances that led to termination.
p.000113: (4) A statement of the investigator’s commitment to:
p.000113: (i) Conduct the investigation in ac- cordance with the agreement, the in- vestigational plan, this part
p.000113: and other applicable FDA regulations, and condi- tions of approval imposed by the re- viewing IRB or FDA;
p.000113: (ii) Supervise all testing of the device involving human subjects; and
p.000113: (iii) Ensure that the requirements for obtaining informed consent are met.
p.000113: (5) Sufficient accurate financial dis- closure information to allow the spon- sor to submit a complete
p.000113: and accurate certification or disclosure statement as required under part 54 of this chapter.
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Food and Drug Administration, HHS § 812.60
p.000114:
p.000114:
p.000114: The sponsor shall obtain a commit- ment from the clinical investigator to promptly update this
p.000114: information if any relevant changes occur during the course of the investigation and for 1 year following
p.000114: completion of the study. This information shall not be sub- mitted in an investigational device ex-
p.000114: emption application, but shall be sub- mitted in any marketing application involving the device.
p.000114: (d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to monitor
p.000114: the inves- tigational study in accordance with this part and other applicable FDA reg- ulations.
p.000114: [45 FR 3751, Jan. 18, 1980, as amended at 63
p.000114: FR 5253, Feb. 2, 1998]
p.000114: § 812.45 Informing investigators.
p.000114: A sponsor shall supply all investiga- tors participating in the investigation with copies of the
p.000114: investigational plan and the report of prior investigations of the device.
p.000114: § 812.46 Monitoring investigations.
p.000114: (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the
p.000114: signed agree- ment, the investigational plan, the re- quirements of this part or other appli- cable FDA
p.000114: regulations, or any condi- tions of approval imposed by the re- viewing IRB or FDA shall promptly ei- ther
p.000114: secure compliance, or discontinue shipments of the device to the investi- gator and terminate the
p.000114: investigator’s participation in the investigation. A sponsor shall also require such an in- vestigator
...
p.000114: sub- jects shall terminate all investigations or parts of investigations presenting that risk as soon as
p.000114: possible. Termi- nation shall occur not later than 5 working days after the sponsor makes this
p.000114: determination and not later than
p.000114:
p.000114: 15 working days after the sponsor first received notice of the effect.
p.000114: (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not
p.000114: resume a termi- nated investigation without IRB and FDA approval. If the device is not a significant
p.000114: risk device, a sponsor may not resume a terminated investigation without IRB approval and, if the inves-
p.000114: tigation was terminated under para- graph (b)(2) of this section, FDA ap- proval.
p.000114: § 812.47 Emergency research under
p.000114: § 50.24 of this chapter.
p.000114: (a) The sponsor shall monitor the progress of all investigations involving an exception from informed
p.000114: consent under § 50.24 of this chapter. When the sponsor receives from the IRB informa- tion concerning the
p.000114: public disclosures under § 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter, the sponsor shall prompt- ly
p.000114: submit to the IDE file and to Docket Number 95S–0158 in the Division of Dockets Management (HFA–305), Food
p.000114: and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, copies of the information that
p.000114: was dis- closed, identified by the IDE number.
p.000114: (b) The sponsor also shall monitor such investigations to determine when an IRB determines that it
p.000114: cannot ap- prove the research because it does not meet the criteria in the exception in
p.000114: § 50.24(a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall
p.000114: provide this in- formation in writing to FDA, inves- tigators who are asked to participate in this
p.000114: or a substantially equivalent clinical investigation, and other IRB’s that are asked to review this or
p.000114: a sub- stantially equivalent investigation.
p.000114: [61 FR 51531, Oct. 2, 1996, as amended at 64 FR
p.000114: 10943, Mar. 8, 1999]
p.000114:
p.000114: Subpart D—IRB Review and Approval
p.000114: § 812.60 IRB composition, duties, and functions.
p.000114: An IRB reviewing and approving in- vestigations under this part shall com- ply with the requirements of part 56 in
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 812.62
p.000115: all respects, including its composition, duties, and functions.
p.000115: [46 FR 8957, Jan. 27, 1981]
p.000115: § 812.62 IRB approval.
p.000115: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000115: approval), or dis- approve all investigations covered by this part.
p.000115: (b) If no IRB exists or if FDA finds that an IRB’s review is inadequate, a sponsor may submit an
p.000115: application to FDA.
p.000115: [46 FR 8957, Jan. 27, 1981]
p.000115: § 812.64 IRB’s continuing review.
...
p.000115: subjects under the investigator’s supervision. An investigator shall not supply an in- vestigational device to
p.000115: any person not authorized under this part to receive it.
p.000115: (d) Financial disclosure. A clinical in- vestigator shall disclose to the sponsor sufficient accurate financial
p.000115: informa- tion to allow the applicant to submit complete and accurate certification or disclosure statements
p.000115: required under part 54 of this chapter. The investi- gator shall promptly update this infor- mation if
p.000115: any relevant changes occur during the course of the investigation and for 1 year following completion of
p.000115: the study.
p.000115: (e) Disposing of device. Upon comple-
p.000115: tion or termination of a clinical inves- tigation or the investigator’s part of an investigation, or at the
p.000115: sponsor’s re- quest, an investigator shall return to the sponsor any remaining supply of the device or
p.000115: otherwise dispose of the device as the sponsor directs.
p.000115: [45 FR 3751, Jan. 18, 1980, as amended at 63
p.000115: FR 5253, Feb. 2, 1998]
p.000115:
p.000115: § 812.119 Disqualification of a clinical investigator.
p.000115: (a) If FDA has information indicating that an investigator has repeatedly or deliberately failed to comply
p.000115: with the requirements of this part, part 50, or part 56 of this chapter, or has repeat- edly or
p.000115: deliberately submitted false in- formation either to the sponsor of the investigation or in any required report,
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116: Food and Drug Administration, HHS § 812.140
p.000116:
p.000116:
p.000116: the Center for Devices and Radio- logical Health, the Center for Biologics Evaluation and Research, or the
p.000116: Center for Drug Evaluation and Research will furnish the investigator written notice of the matter under
p.000116: complaint and offer the investigator an opportunity to explain the matter in writing, or, at the option of the
p.000116: investigator, in an in- formal conference. If an explanation is offered and accepted by the applicable
p.000116: Center, the disqualification process will be terminated. If an explanation is offered but not accepted by the
p.000116: Center, the investigator will be given an oppor- tunity for a regulatory hearing under part 16 of this chapter
p.000116: on the question of whether the investigator is entitled to receive investigational devices.
p.000116: (b) After evaluating all available in-
p.000116: formation, including any explanation presented by the investigator, if the Commissioner determines
p.000116: that the in- vestigator has repeatedly or delib- erately failed to comply with the re- quirements
p.000116: of this part, part 50, or part
p.000116: 56 of this chapter, or has deliberately or repeatedly submitted false informa- tion either to the sponsor of
p.000116: the inves- tigation or in any required report, the Commissioner will notify the investi- gator, the sponsor
p.000116: of any investigation in which the investigator has been named as a participant, and the review- ing IRB that
p.000116: the investigator is not en- titled to receive investigational de- vices. The notification will provide a
p.000116: statement of basis for such determina- tion.
p.000116: (c) Each investigational device ex-
p.000116: emption (IDE) and each cleared or ap- proved application submitted under this part, subpart E of
...
p.000117: § 812.2(b)(1) of a device other than a sig- nificant risk device, the records de- scribed in paragraph
p.000117: (b)(5) of this sec- tion and the following records, consoli- dated in one location and available for FDA
p.000117: inspection and copying:
p.000117: (i) The name and intended use of the device and the objectives of the inves- tigation;
p.000117: (ii) A brief explanation of why the de- vice is not a significant risk device:
p.000117: (iii) The name and address of each in- vestigator:
p.000117: (iv) The name and address of each IRB that has reviewed the investiga- tion:
p.000117: (v) A statement of the extent to which the good manufacturing practice regulation in part 820 will be
p.000117: followed in manufacturing the device; and
p.000117: (vi) Any other information required by FDA.
p.000117: (5) Records concerning adverse device effects (whether anticipated or unan- ticipated) and complaints and
p.000117: (6) Any other records that FDA re- quires to be maintained by regulation or by specific requirement for
p.000117: a cat- egory of investigation or a particular investigation.
p.000117: (c) IRB records. An IRB shall main- tain records in accordance with part 56 of this chapter.
p.000117: (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart
p.000117: during the in- vestigation and for a period of 2 years after the latter of the following two dates: The
p.000117: date on which the investiga- tion is terminated or completed, or the
p.000118: 118
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Food and Drug Administration, HHS § 812.150
p.000118:
p.000118:
p.000118: date that the records are no longer re- quired for purposes of supporting a pre- market approval application
p.000118: or a no- tice of completion of a product devel- opment protocol.
p.000118: (e) Records custody. An investigator or sponsor may withdraw from the re- sponsibility to maintain records
p.000118: for the period required in paragraph (d) of this section and transfer custody of the records to any other
p.000118: person who will accept responsibility for them under this part, including the requirements of § 812.145.
p.000118: Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
p.000118: [45 FR 3751, Jan. 18, 1980, as amended at 45
p.000118: FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27,
p.000118: 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb.
p.000118: 2, 1998]
p.000118:
p.000118: § 812.145 Inspections.
p.000118: (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit
p.000118: authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any
p.000118: establishment where devices are held (including any estab- lishment where devices are manufac- tured,
p.000118: processed, packed, installed, used, or implanted or where records of results from use of devices are kept).
p.000118: (b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such
...
Health / Physically Disabled
Searching for indicator illness:
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p.000111: § 812.19, unless FDA notifies the sponsor in writing earlier than the 30 days that the treatment use may or
p.000111: may not begin. FDA may approve the treatment use as proposed or approve it with modifications.
p.000112: 112
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112: Food and Drug Administration, HHS § 812.38
p.000112:
p.000112:
p.000112: (2) Disapproval or ithdra al of ap- proval of treatment IDE’s. FDA may dis- approve or withdraw
p.000112: approval of a treatment IDE if:
p.000112: (i) The criteria specified in § 812.36(b) are not met or the treatment IDE does not contain the information
p.000112: required in § 812.36(c);
p.000112: (ii) FDA determines that any of the grounds for disapproval or withdrawal of approval listed in
p.000112: § 812.30(b)(1) through (b)(5) apply;
p.000112: (iii) The device is intended for a seri- ous disease or condition and there is insufficient evidence of safety
p.000112: and ef- fectiveness to support such use;
p.000112: (iv) The device is intended for an im- mediately life-threatening disease or condition and the available
p.000112: scientific evidence, taken as a whole, fails to pro- vide a reasonable basis for concluding that the device:
p.000112: (A) May be effective for its intended use in its intended population; or
p.000112: (B) Would not expose the patients to whom the device is to be administered to an unreasonable and
p.000112: significant ad- ditional risk of illness or injury;
p.000112: (v) There is reasonable evidence that the treatment use is impeding enroll- ment in, or otherwise
p.000112: interfering with the conduct or completion of, a con- trolled investigation of the same or an- other
p.000112: investigational device;
p.000112: (vi) The device has received mar- keting approval/clearance or a com- parable device or
p.000112: therapy becomes available to treat or diagnose the same indication in the same patient popu- lation for which
p.000112: the investigational de- vice is being used;
p.000112: (vii) The sponsor of the controlled clinical trial is not pursuing marketing approval/clearance with due
p.000112: diligence;
p.000112: (viii) Approval of the IDE for the con- trolled clinical investigation of the de- vice has been withdrawn; or
p.000112: (ix) The clinical investigator(s) named in the treatment IDE are not qualified by reason of their
p.000112: scientific training and/or experience to use the investigational device for the intended treatment use.
p.000112: (3) Notice of disapproval or ithdra al. If FDA disapproves or proposes to with- draw approval of a
p.000112: treatment IDE, FDA will follow the procedures set forth in § 812.30(c).
p.000112:
p.000112: (e) Safeguards. Treatment use of an investigational device is conditioned upon the sponsor and
p.000112: investigators complying with the safeguards of the IDE process and the regulations gov- erning informed
p.000112: consent (part 50 of this chapter) and institutional review boards (part 56 of this chapter).
p.000112: (f) Reporting requirements. The spon- sor of a treatment IDE shall submit progress reports on a semi-annual
...
Health / ill
Searching for indicator ill:
(return to top)
p.000110: the in- formation required by § 812.20(b) and (c) and a description of any modifications in the investigational
p.000110: plan required by the IRB as a condition of approval. A certification of IRB approval need not be
p.000110: included in the initial submission of the supplemental application, and such certification is not a precondition
p.000110: for agency consideration of the applica- tion. Nevertheless, a sponsor may not begin a part of an
p.000110: investigation at a fa- cility until the IRB has approved the investigation, FDA has received the
p.000110: certification of IRB approval, and FDA, under § 812.30(a), has approved the sup- plemental application relating
p.000110: to that part of the investigation (see
p.000110: § 56.103(a)).
p.000110: [50 FR 25909, June 24, 1985; 50 FR 28932, July
p.000110: 17, 1985, as amended at 61 FR 51531, Oct. 2,
p.000110: 1996; 63 FR 64625, Nov. 23, 1998]
p.000110:
p.000110: § 812.36 Treatment use of an investiga- tional device.
p.000110: (a) General. A device that is not ap- proved for marketing may be under clinical investigation for
p.000110: a serious or immediately life-threatening disease or condition in patients for whom no com- parable or satisfactory
p.000110: alternative de- vice or other therapy is available. Dur- ing the clinical trial or prior to final action on
p.000110: the marketing application, it may be appropriate to use the device in the treatment of patients not in the trial
p.000110: under the provisions of a treat- ment investigational device exemption (IDE). The purpose of this section is to
p.000110: facilitate the availability of promising new devices to desperately ill patients as early in the
p.000110: device development
p.000111: 111
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: § 812.36
p.000111: process as possible, before general mar- keting begins, and to obtain additional data on the device’s safety and
p.000111: effec- tiveness. In the case of a serious dis- ease, a device ordinarily may be made available for
p.000111: treatment use under this section after all clinical trials have been completed. In the case of an
p.000111: im- mediately life-threatening disease, a device may be made available for treat- ment use under this section
p.000111: prior to the completion of all clinical trials. For the purpose of this section, an
p.000111: ‘‘immediately life-threatening’’ disease means a stage of a disease in which there is a reasonable
p.000111: likelihood that death will occur within a matter of months or in which premature death is likely without
p.000111: early treatment. For purposes of this section, ‘‘treatment use’’of a device includes the use of a de-
p.000111: vice for diagnostic purposes.
p.000111: (b) Criteria. FDA shall consider the
p.000111: use of an investigational device under a treatment IDE if:
p.000111: (1) The device is intended to treat or diagnose a serious or immediately life- threatening disease or condition;
p.000111: (2) There is no comparable or satis- factory alternative device or other therapy available to
p.000111: treat or diagnose that stage of the disease or condition in the intended patient population;
p.000111: (3) The device is under investigation in a controlled clinical trial for the same use under an
p.000111: approved IDE, or such clinical trials have been com- pleted; and
...
Social / Access to Social Goods
Searching for indicator access:
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p.000117: (c) IRB records. An IRB shall main- tain records in accordance with part 56 of this chapter.
p.000117: (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart
p.000117: during the in- vestigation and for a period of 2 years after the latter of the following two dates: The
p.000117: date on which the investiga- tion is terminated or completed, or the
p.000118: 118
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Food and Drug Administration, HHS § 812.150
p.000118:
p.000118:
p.000118: date that the records are no longer re- quired for purposes of supporting a pre- market approval application
p.000118: or a no- tice of completion of a product devel- opment protocol.
p.000118: (e) Records custody. An investigator or sponsor may withdraw from the re- sponsibility to maintain records
p.000118: for the period required in paragraph (d) of this section and transfer custody of the records to any other
p.000118: person who will accept responsibility for them under this part, including the requirements of § 812.145.
p.000118: Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
p.000118: [45 FR 3751, Jan. 18, 1980, as amended at 45
p.000118: FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27,
p.000118: 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb.
p.000118: 2, 1998]
p.000118:
p.000118: § 812.145 Inspections.
p.000118: (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit
p.000118: authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any
p.000118: establishment where devices are held (including any estab- lishment where devices are manufac- tured,
p.000118: processed, packed, installed, used, or implanted or where records of results from use of devices are kept).
p.000118: (b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such
p.000118: a person with respect to an investigation, shall per- mit authorized FDA employees, at rea- sonable times and in
p.000118: a reasonable man- ner, to inspect and copy all records re- lating to an investigation.
p.000118: (c) Records identifying subjects. An in- vestigator shall permit authorized FDA employees to inspect and copy
p.000118: records that identify subjects, upon notice that FDA has reason to suspect that ade- quate informed consent
p.000118: was not ob- tained, or that reports required to be submitted by the investigator to the sponsor or
p.000118: IRB have not been sub- mitted or are incomplete, inaccurate, false, or misleading.
p.000118: § 812.150 Reports.
p.000118: (a) Investigator reports. An investi- gator shall prepare and submit the fol- lowing complete, accurate, and
p.000118: timely reports:
p.000118:
p.000118: (1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the
p.000118: reviewing IRB a re- port of any unanticipated adverse de- vice effect occurring during an inves- tigation
...
Searching for indicator freedomXofXinformation:
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p.000112: (2) If a device is a banned device or if the existence of an IDE has been pub- licly disclosed or
p.000112: acknowledged, data or information contained in the file is
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: § 812.40
p.000113: not available for public disclosure be- fore approval of an application for pre- market approval or the
p.000113: effective date of a notice of completion of a product development protocol except as pro- vided in
p.000113: this section. FDA may, in its discretion, disclose a summary of se- lected portions of the safety and
p.000113: effec- tiveness data, that is, clinical, animal, or laboratory studies and tests of the device, for
p.000113: public consideration of a specific pending issue.
p.000113: (3) If the existence of an IDE file has
p.000113: not been publicly disclosed or acknowl- edged, no data or information in the file are available for public
p.000113: disclosure except as provided in paragraphs (b)(1) and (c) of this section.
p.000113: (4) Notwithstanding paragraph (b)(2) of this section, FDA will make avail- able to the public, upon request,
p.000113: the in- formation in the IDE that was required to be filed in Docket Number 95S–0158 in the Division of Dockets
p.000113: Management (HFA–305), Food and Drug Administra- tion, 5630 Fishers Lane, rm. 1061, Rock- ville, MD 20852, for
p.000113: investigations in- volving an exception from informed consent under § 50.24 of this chapter. Persons
p.000113: wishing to request this infor- mation shall submit a request under the Freedom of Information Act.
p.000113: (c) Reports of adverse effects. Upon re-
p.000113: quest or on its own initiative, FDA shall disclose to an individual on whom an investigational device has
p.000113: been used a copy of a report of adverse device ef- fects relating to that use.
p.000113: (d) Other rules. Except as otherwise provided in this section, the avail- ability for public
p.000113: disclosure of data and information in an IDE file shall be han- dled in accordance with § 814.9.
p.000113: [45 FR 3751, Jan. 18, 1980, as amended at 53
p.000113: FR 11253, Apr. 6, 1988; 61 FR 51531, Oct. 2,
p.000113: 1996]
p.000113:
p.000113: Subpart C—Responsibilities of Sponsors
p.000113: § 812.40 General responsibilities of sponsors.
p.000113: Sponsors are responsible for selecting qualified investigators and providing them with the information they
p.000113: need to conduct the investigation properly, ensuring proper monitoring of the in- vestigation, ensuring that
p.000113: IRB review and approval are obtained, submitting
p.000113: 21 CFR Ch. I (4–1–11 Edition)
p.000113: an IDE application to FDA, and ensur- ing that any reviewing IRB and FDA are promptly informed of
p.000113: significant new information about an investiga- tion. Additional responsibilities of sponsors are
p.000113: described in subparts B and G.
p.000113: § 812.42 FDA and IRB approval.
p.000113: A sponsor shall not begin an inves- tigation or part of an investigation until an IRB and FDA have
p.000113: both ap- proved the application or supplemental application relating to the investiga- tion or part of an
p.000113: investigation.
p.000113: [46 FR 8957, Jan. 27, 1981]
p.000113:
p.000113: § 812.43 Selecting investigators and monitors.
...
Social / Age
Searching for indicator age:
(return to top)
p.000107: the application for pur-
p.000107: 21 CFR Ch. I (4–1–11 Edition)
p.000107: poses of requesting a hearing under part 16.
p.000107: (d) Information previously submitted. Information previously submitted to the Center for Devices
p.000107: and Radio- logical Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and
p.000107: Research, as applicable, in accordance with this chapter ordinarily need not be resub- mitted, but
p.000107: may be incorporated by reference.
p.000107: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000107: FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26,
p.000107: 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530,
p.000107: Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR
p.000107: 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008]
p.000107:
p.000107: § 812.25 Investigational plan.
p.000107: The investigational plan shall in- clude, in the following order:
p.000107: (a) Purpose. The name and intended use of the device and the objectives and duration of the investigation.
p.000107: (b) Protocol. A written protocol de- scribing the methodology to be used and an analysis of the
p.000107: protocol dem- onstrating that the investigation is scientifically sound.
p.000107: (c) Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by
p.000107: the inves- tigation; the manner in which these risks will be minimized; a justification for the
p.000107: investigation; and a description of the patient population, including the number, age, sex, and condition.
p.000107: (d) Description of device. A description of each important component, ingre- dient, property, and
p.000107: principle of oper- ation of the device and of each antici- pated change in the device during the course
p.000107: of the investigation.
p.000107: (e) Monitoring procedures. The spon- sor’s written procedures for monitoring the investigation and the name and
p.000107: ad- dress of any monitor.
p.000107: (f) Labeling. Copies of all labeling for the device.
p.000107: (g) Consent materials. Copies of all forms and informational materials to be provided to subjects to
p.000107: obtain in- formed consent.
p.000107: (h) IRB information. A list of the names, locations, and chairpersons of all IRB’s that have
p.000107: been or will be asked to review the investigation, and a certification of any action taken by
p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Food and Drug Administration, HHS § 812.30
p.000108:
p.000108:
p.000108: any of those IRB’s with respect to the investigation.
p.000108: (i) Other institutions. The name and address of each institution at which a part of the investigation
p.000108: may be con- ducted that has not been identified in paragraph (h) of this section.
p.000108: (j) Additional records and reports. A de- scription of records and reports that will be maintained on the
p.000108: investigation in addition to those prescribed in sub- part G.
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Food and Drug Administration, HHS § 812.2
p.000102:
p.000102: Subpart A—General Provisions
p.000102: § 812.1 Scope.
p.000102: (a) The purpose of this part is to en- courage, to the extent consistent with the protection of
p.000102: public health and safety and with ethical standards, the discovery and development of useful devices
p.000102: intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pur- suit of
p.000102: this purpose. This part provides procedures for the conduct of clinical investigations of devices. An approved
p.000102: investigational device exemption (IDE) permits a device that otherwise would be required to comply with a
p.000102: perform- ance standard or to have premarket ap- proval to be shipped lawfully for the purpose of conducting
p.000102: investigations of that device. An IDE approved under
p.000102: § 812.30 or considered approved under
p.000102: § 812.2(b) exempts a device from the re- quirements of the following sections of the Federal Food, Drug, and
p.000102: Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act,
p.000102: registration, listing, and premarket notification under section 510, performance standards under sec- tion
p.000102: 514, premarket approval under sec- tion 515, a banned device regulation under section 516, records and
p.000102: reports under section 519, restricted device re- quirements under section 520(e), good manufacturing
p.000102: practice requirements under section 520(f) except for the re- quirements found in § 820.30, if applica-
p.000102: ble (unless the sponsor states an inten- tion to comply with these require- ments under §
p.000102: 812.20(b)(3) or
p.000102: § 812.140(b)(4)(v)) and color additive re-
p.000102: quirements under section 721.
p.000102: (b) References in this part to regu- latory sections of the Code of Federal Regulations are to chapter I of
p.000102: title 21, unless otherwise noted.
p.000102: [45 FR 3751, Jan. 18, 1980, as amended at 59
p.000102: FR 14366, Mar. 28, 1994; 61 FR 52654, Oct. 7,
p.000102: 1996]
p.000102: § 812.2 Applicability.
p.000102: (a) General. This part applies to all clinical investigations of devices to de- termine safety and
p.000102: effectiveness, ex- cept as provided in paragraph (c) of this section.
p.000102: (b) Abbreviated requirements. The fol- lowing categories of investigations are
p.000102:
p.000102: considered to have approved applica- tions for IDE’s, unless FDA has noti- fied a sponsor under §
p.000102: 812.20(a) that ap- proval of an application is required:
p.000102: (1) An investigation of a device other than a significant risk device, if the de- vice is not a banned device
p.000102: and the sponsor:
p.000102: (i) Labels the device in accordance with § 812.5;
p.000102: (ii) Obtains IRB approval of the in- vestigation after presenting the re- viewing IRB with a brief
p.000102: explanation of why the device is not a significant risk device, and maintains such approval;
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000103: approval requirement in order to com- ply with the order of an individual phy- sician or dentist;
p.000103: (2) Is not generally available to, or generally used by, other physicians or dentists;
p.000103: (3) Is not generally available in fin- ished form for purchase or for dis- pensing upon prescription;
p.000103: (4) Is not offered for commercial dis- tribution through labeling or adver- tising; and
p.000103: (5) Is intended for use by an indi- vidual patient named in the order of a physician or dentist,
p.000103: and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician
p.000103: or dentist in the course of professional practice.
p.000103: (c) FDA means the Food and Drug Administration.
p.000103: (d) Implant means a device that is placed into a surgically or naturally formed cavity of the
p.000103: human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect
p.000103: public health, determine that devices placed in subjects for shorter periods are also ‘‘implants’’ for
p.000103: purposes of this part.
p.000103: (e) Institution means a person, other than an individual, who engages in the conduct of research on
p.000103: subjects or in the delivery of medical services to indi- viduals as a primary activity or as an adjunct to
p.000103: providing residential or cus- todial care to humans. The term in- cludes, for example, a hospital, retire-
p.000103: ment home, confinement facility, aca- demic establishment, and device manu- facturer. The term has the same mean-
p.000103: ing as ‘‘facility’’ in section 520(g) of the act.
p.000104: 104
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Food and Drug Administration, HHS § 812.3
p.000104:
p.000104:
p.000104: (f) Institutional revie board (IRB) means any board, committee, or other group formally designated
p.000104: by an insti- tution to review biomedical research involving subjects and established, op- erated, and
p.000104: functioning in conformance with part 56. The term has the same meaning as ‘‘institutional review com-
p.000104: mittee’’ in section 520(g) of the act.
p.000104: (g) Investigational device means a de- vice, including a transitional device, that is the object of an
p.000104: investigation.
p.000104: (h) Investigation means a clinical in- vestigation or research involving one or more subjects to determine the
p.000104: safe- ty or effectiveness of a device.
p.000104: (i) Investigator means an individual who actually conducts a clinical inves- tigation, i.e., under whose
p.000104: immediate direction the test article is adminis- tered or dispensed to, or used involv- ing, a subject, or,
p.000104: in the event of an in- vestigation conducted by a team of in- dividuals, is the responsible leader of that
p.000104: team.
p.000104: (j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research
p.000104: organiza- tion to oversee the progress of an in- vestigation. The monitor may be an employee of a
...
Searching for indicator property:
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p.000107: (d) Information previously submitted. Information previously submitted to the Center for Devices
p.000107: and Radio- logical Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and
p.000107: Research, as applicable, in accordance with this chapter ordinarily need not be resub- mitted, but
p.000107: may be incorporated by reference.
p.000107: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000107: FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26,
p.000107: 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530,
p.000107: Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR
p.000107: 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008]
p.000107:
p.000107: § 812.25 Investigational plan.
p.000107: The investigational plan shall in- clude, in the following order:
p.000107: (a) Purpose. The name and intended use of the device and the objectives and duration of the investigation.
p.000107: (b) Protocol. A written protocol de- scribing the methodology to be used and an analysis of the
p.000107: protocol dem- onstrating that the investigation is scientifically sound.
p.000107: (c) Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by
p.000107: the inves- tigation; the manner in which these risks will be minimized; a justification for the
p.000107: investigation; and a description of the patient population, including the number, age, sex, and condition.
p.000107: (d) Description of device. A description of each important component, ingre- dient, property, and
p.000107: principle of oper- ation of the device and of each antici- pated change in the device during the course
p.000107: of the investigation.
p.000107: (e) Monitoring procedures. The spon- sor’s written procedures for monitoring the investigation and the name and
p.000107: ad- dress of any monitor.
p.000107: (f) Labeling. Copies of all labeling for the device.
p.000107: (g) Consent materials. Copies of all forms and informational materials to be provided to subjects to
p.000107: obtain in- formed consent.
p.000107: (h) IRB information. A list of the names, locations, and chairpersons of all IRB’s that have
p.000107: been or will be asked to review the investigation, and a certification of any action taken by
p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Food and Drug Administration, HHS § 812.30
p.000108:
p.000108:
p.000108: any of those IRB’s with respect to the investigation.
p.000108: (i) Other institutions. The name and address of each institution at which a part of the investigation
p.000108: may be con- ducted that has not been identified in paragraph (h) of this section.
p.000108: (j) Additional records and reports. A de- scription of records and reports that will be maintained on the
p.000108: investigation in addition to those prescribed in sub- part G.
p.000108: § 812.27 Report of prior investigations.
p.000108: (a) General. The report of prior inves- tigations shall include reports of all prior clinical, animal,
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000110: turing change to the device, the notice shall include a summary of the rel- evant information gathered
p.000110: during the course of the investigation upon which the change was based; a description of the change to
p.000110: the device or manufac- turing process (cross-referenced to the appropriate sections of the original de- vice
p.000110: description or manufacturing process); and, if design controls were used to assess the change, a
p.000110: statement that no new risks were identified by appropriate risk analysis and that the verification and
p.000110: validation testing, as appropriate, demonstrated that the de- sign outputs met the design input re-
p.000110: quirements. If another method of as- sessment was used, the notice shall in- clude a summary of the
p.000110: information which served as the credible informa- tion supporting the change.
p.000110: (B) For a protocol change, the notice
p.000110: shall include a description of the change (cross-referenced to the appro- priate sections of
p.000110: the original pro- tocol); an assessment supporting the conclusion that the change does not have
p.000110: a significant impact on the study design or planned statistical analysis; and a summary of the information
p.000110: that served as the credible information sup- porting the sponsor’s determination that the change does not
p.000110: affect the rights, safety, or welfare of the sub- jects.
p.000110: (4) Changes submitted in annual report. The requirements of paragraph (a)(1) of this section do not apply
p.000110: to minor changes to the purpose of the study,
p.000110: risk analysis, monitoring procedures, labeling, informed consent materials, and IRB information that do not
p.000110: affect:
p.000110: (i) The validity of the data or infor- mation resulting from the completion of the approved protocol, or
p.000110: the rela-
p.000110:
p.000110: tionship of likely patient risk to ben- efit relied upon to approve the pro- tocol;
p.000110: (ii) The scientific soundness of the investigational plan; or
p.000110: (iii) The rights, safety, or welfare of the human subjects involved in the in- vestigation. Such changes
p.000110: shall be re- ported in the annual progress report for the IDE, under § 812.150(b)(5).
p.000110: (b) IRB approval for ne facilities. A sponsor shall submit to FDA a certifi- cation of any IRB approval of
p.000110: an inves- tigation or a part of an investigation not included in the IDE application. If the
p.000110: investigation is otherwise un- changed, the supplemental application shall consist of an updating of
p.000110: the in- formation required by § 812.20(b) and (c) and a description of any modifications in the investigational
p.000110: plan required by the IRB as a condition of approval. A certification of IRB approval need not be
p.000110: included in the initial submission of the supplemental application, and such certification is not a precondition
p.000110: for agency consideration of the applica- tion. Nevertheless, a sponsor may not begin a part of an
...
Social / employees
Searching for indicator employees:
(return to top)
p.000104: organizational unit of a Government agency, and any other legal entity.
p.000104:
p.000104: (m) Significant risk device means an investigational device that:
p.000104: (1) Is intended as an implant and pre- sents a potential for serious risk to the health, safety, or welfare of a
p.000104: subject;
p.000104: (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a
p.000104: potential for serious risk to the health, safety, or welfare of a subject;
p.000104: (3) Is for a use of substantial impor- tance in diagnosing, curing, miti- gating, or treating
p.000104: disease, or other- wise preventing impairment of human health and presents a potential for se- rious risk
p.000104: to the health, safety, or wel- fare of a subject; or
p.000104: (4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
p.000104: (n) Sponsor means a person who initi- ates, but who does not actually con- duct, the investigation, that is,
p.000104: the in- vestigational device is administered, dispensed, or used under the immediate direction of another
p.000104: individual. A per- son other than an individual that uses one or more of its own employees to conduct
p.000104: an investigation that it has initiated is a sponsor, not a sponsor-in- vestigator, and the employees are
p.000104: in- vestigators.
p.000104: (o) Sponsor-investigator means an indi- vidual who both initiates and actually conducts, alone or with others,
p.000104: an in- vestigation, that is, under whose im-
p.000104: mediate direction the investigational device is administered, dispensed, or used. The term does not
p.000104: include any person other than an individual. The obligations of a sponsor-investigator under this part
p.000104: include those of an in- vestigator and those of a sponsor.
p.000104: (p) Subject means a human who par- ticipates in an investigation, either as an individual on whom or
p.000104: on whose specimen an investigational device is used or as a control. A subject may be in normal
p.000104: health or may have a med- ical condition or disease.
p.000104: (q) Termination means a discontinu- ance, by sponsor or by withdrawal of IRB or FDA approval, of an
p.000104: investiga- tion before completion.
p.000104: (r) Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA
p.000104: considered to be a new drug or an antibiotic drug before May 28, 1976.
p.000105: 105
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: § 812.5
p.000105: (s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any
p.000105: life-threatening problem or death caused by, or associ- ated with, a device, if that effect, prob- lem, or
p.000105: death was not previously iden- tified in nature, severity, or degree of incidence in the investigational plan
...
p.000117: (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart
p.000117: during the in- vestigation and for a period of 2 years after the latter of the following two dates: The
p.000117: date on which the investiga- tion is terminated or completed, or the
p.000118: 118
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Food and Drug Administration, HHS § 812.150
p.000118:
p.000118:
p.000118: date that the records are no longer re- quired for purposes of supporting a pre- market approval application
p.000118: or a no- tice of completion of a product devel- opment protocol.
p.000118: (e) Records custody. An investigator or sponsor may withdraw from the re- sponsibility to maintain records
p.000118: for the period required in paragraph (d) of this section and transfer custody of the records to any other
p.000118: person who will accept responsibility for them under this part, including the requirements of § 812.145.
p.000118: Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
p.000118: [45 FR 3751, Jan. 18, 1980, as amended at 45
p.000118: FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27,
p.000118: 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb.
p.000118: 2, 1998]
p.000118:
p.000118: § 812.145 Inspections.
p.000118: (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit
p.000118: authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any
p.000118: establishment where devices are held (including any estab- lishment where devices are manufac- tured,
p.000118: processed, packed, installed, used, or implanted or where records of results from use of devices are kept).
p.000118: (b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such
p.000118: a person with respect to an investigation, shall per- mit authorized FDA employees, at rea- sonable times and in
p.000118: a reasonable man- ner, to inspect and copy all records re- lating to an investigation.
p.000118: (c) Records identifying subjects. An in- vestigator shall permit authorized FDA employees to inspect and copy
p.000118: records that identify subjects, upon notice that FDA has reason to suspect that ade- quate informed consent
p.000118: was not ob- tained, or that reports required to be submitted by the investigator to the sponsor or
p.000118: IRB have not been sub- mitted or are incomplete, inaccurate, false, or misleading.
p.000118: § 812.150 Reports.
p.000118: (a) Investigator reports. An investi- gator shall prepare and submit the fol- lowing complete, accurate, and
p.000118: timely reports:
p.000118:
p.000118: (1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the
p.000118: reviewing IRB a re- port of any unanticipated adverse de- vice effect occurring during an inves- tigation
p.000118: as soon as possible, but in no event later than 10 working days after the investigator first learns of
p.000118: the ef- fect.
p.000118: (2) Withdra al of IRB approval. An in- vestigator shall report to the sponsor, within 5 working days, a
p.000118: withdrawal of approval by the reviewing IRB of the investigator’s part of an investigation.
p.000118: (3) Progress. An investigator shall submit progress reports on the inves- tigation to the sponsor,
p.000118: the monitor, and the reviewing IRB at regular inter- vals, but in no event less often than yearly.
p.000118: (4) Deviations from the investigational plan. An investigator shall notify the sponsor and the reviewing
p.000118: IRB (see
p.000118: § 56.108(a) (3) and (4)) of any deviation from the investigational plan to pro- tect the life or physical
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000102: The agency will make available to the public in the weekly FDA Enforce- ment Report a descriptive
p.000102: listing of each new mandatory recall issued under § 810.13. The agency will delay public
p.000102: notification of orders when the agency determines that such notifica- tion may cause unnecessary and harm- ful
p.000102: anxiety in individuals and that ini- tial consultation between individuals and their health professionals
p.000102: is essen- tial.
p.000102:
p.000102: PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
p.000102: Subpart A—General Provisions
p.000102: Sec.
p.000102: 812.1 Scope.
p.000102:
p.000102: 21 CFR Ch. I (4–1–11 Edition)
p.000102: 812.2 Applicability.
p.000102: 812.3 Definitions.
p.000102: 812.5 Labeling of investigational devices.
p.000102: 812.7 Prohibition of promotion and other practices.
p.000102: 812.10 Waivers.
p.000102: 812.18 Import and export requirements.
p.000102: 812.19 Address for IDE correspondence.
p.000102:
p.000102: Subpart B—Application and Administrative Action
p.000102: 812.20 Application.
p.000102: 812.25 Investigational plan.
p.000102: 812.27 Report of prior investigations.
p.000102: 812.30 FDA action on applications.
p.000102: 812.35 Supplemental applications.
p.000102: 812.36 Treatment use of an investigational device.
p.000102: 812.38 Confidentiality of data and informa- tion.
p.000102:
p.000102: Subpart C—Responsibilities of Sponsors
p.000102: 812.40 General responsibilities of sponsors.
p.000102: 812.42 FDA and IRB approval.
p.000102: 812.43 Selecting investigators and monitors.
p.000102: 812.45 Informing investigators.
p.000102: 812.46 Monitoring investigations.
p.000102: 812.47 Emergency research under § 50.24 of this chapter.
p.000102:
p.000102: Subpart D—IRB Review and Approval
p.000102: 812.60 IRB composition, duties, and func- tions.
p.000102: 812.62 IRB approval.
p.000102: 812.64 IRB’s continuing review.
p.000102: 812.65 [Reserved]
p.000102: 812.66 Significant risk device determina- tions.
p.000102:
p.000102: Subpart E—Responsibilities of Investigators
p.000102: 812.100 General responsibilities of investiga- tors.
p.000102: 812.110 Specific responsibilities of investiga- tors.
p.000102: 812.119 Disqualification of a clinical investi- gator.
p.000102:
p.000102: Subpart F [Reserved]
p.000102: Subpart G—Records and Reports
p.000102: 812.140 Records.
p.000102: 812.145 Inspections.
p.000102: 812.150 Reports.
p.000102: AUTHORITY: 21 U.S.C. 331, 351, 352, 353, 355,
p.000102: 360, 360c–360f, 360h–360j, 371, 372, 374, 379e, 381,
p.000102: 382, 383; 42 U.S.C. 216, 241, 262, 263b–263n.
p.000102: SOURCE: 45 FR 3751, Jan. 18, 1980, unless
p.000102: otherwise noted.
p.000102: 102
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Food and Drug Administration, HHS § 812.2
p.000102:
p.000102: Subpart A—General Provisions
p.000102: § 812.1 Scope.
p.000102: (a) The purpose of this part is to en- courage, to the extent consistent with the protection of
p.000102: public health and safety and with ethical standards, the discovery and development of useful devices
...
p.000108: the sponsor has an opportunity to request a hearing under part 16.
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: § 812.35
p.000109: (2) A notice of a proposed withdrawal of approval will contain a complete statement of the reasons
p.000109: for with- drawal and a statement that the spon- sor has an opportunity to request a hearing under
p.000109: part 16. FDA will provide the opportunity for hearing before withdrawal of approval, unless FDA de-
p.000109: termines in the notice that continu- ation of testing under the exemption will result in an unreasonble
p.000109: risk to the public health and orders with- drawal of approval before any hearing.
p.000109: [45 FR 3751, Jan. 18, 1980, as amended at 45
p.000109: FR 58842, Sept. 5, 1980]
p.000109: § 812.35 Supplemental applications.
p.000109: (a) Changes in investigational plan—(1) Changes requiring prior approval. Except as described in
p.000109: paragraphs (a)(2) through (a)(4) of this section, a sponsor must obtain approval of a supple- mental
p.000109: application under § 812.30(a), and IRB approval when appropriate (see §§ 56.110 and 56.111 of
p.000109: this chapter), prior to implementing a change to an investigational plan. If a sponsor in- tends to
p.000109: conduct an investigation that involves an exception to informed con- sent under § 50.24 of this chapter,
p.000109: the sponsor shall submit a separate inves- tigational device exemption (IDE) ap- plication in accordance
p.000109: with § 812.20(a).
p.000109: (2) Changes effected for emergency use.
p.000109: The requirements of paragraph (a)(1) of this section regarding FDA approval of a supplement do not apply in the
p.000109: case of a deviation from the investigational plan to protect the life or physical well-being of a
p.000109: subject in an emer- gency. Such deviation shall be reported to FDA within 5-working days after the sponsor
p.000109: learns of it (see § 812.150(a)(4)).
p.000109: (3) Changes effected ith notice to FDA ithin 5 days. A sponsor may make cer- tain changes without prior
p.000109: approval of a supplemental application under para- graph (a)(1) of this section if the spon- sor determines
p.000109: that these changes meet the criteria described in para-
p.000109: graphs (a)(3)(i) and (a)(3)(ii) of this sec- tion, on the basis of credible informa- tion defined in paragraph
p.000109: (a)(3)(iii) of this section, and the sponsor provides notice to FDA within 5-working days of making these
p.000109: changes.
p.000109: (i) Developmental changes. The re- quirements in paragraph (a)(1) of this section regarding FDA
p.000109: approval of a
p.000109: 21 CFR Ch. I (4–1–11 Edition)
p.000109: supplement do not apply to develop- mental changes in the device (includ- ing manufacturing changes)
p.000109: that do not constitute a significant change in design or basic principles of operation and that are made
p.000109: in response to infor- mation gathered during the course of an investigation.
p.000109: (ii) Changes to clinical protocol. The requirements in paragraph (a)(1) of this section regarding FDA
p.000109: approval of a supplement do not apply to changes to clinical protocols that do not affect:
...
p.000114: investigator’s participation in the investigation. A sponsor shall also require such an in- vestigator
p.000114: to dispose of or return the device, unless this action would jeop- ardize the rights, safety, or welfare of a
p.000114: subject.
p.000114: (b) Unanticipated adverse device effects.
p.000114: (1) A sponsor shall immediately con- duct an evaluation of any unantici- pated adverse device effect.
p.000114: (2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to
p.000114: sub- jects shall terminate all investigations or parts of investigations presenting that risk as soon as
p.000114: possible. Termi- nation shall occur not later than 5 working days after the sponsor makes this
p.000114: determination and not later than
p.000114:
p.000114: 15 working days after the sponsor first received notice of the effect.
p.000114: (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not
p.000114: resume a termi- nated investigation without IRB and FDA approval. If the device is not a significant
p.000114: risk device, a sponsor may not resume a terminated investigation without IRB approval and, if the inves-
p.000114: tigation was terminated under para- graph (b)(2) of this section, FDA ap- proval.
p.000114: § 812.47 Emergency research under
p.000114: § 50.24 of this chapter.
p.000114: (a) The sponsor shall monitor the progress of all investigations involving an exception from informed
p.000114: consent under § 50.24 of this chapter. When the sponsor receives from the IRB informa- tion concerning the
p.000114: public disclosures under § 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter, the sponsor shall prompt- ly
p.000114: submit to the IDE file and to Docket Number 95S–0158 in the Division of Dockets Management (HFA–305), Food
p.000114: and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, copies of the information that
p.000114: was dis- closed, identified by the IDE number.
p.000114: (b) The sponsor also shall monitor such investigations to determine when an IRB determines that it
p.000114: cannot ap- prove the research because it does not meet the criteria in the exception in
p.000114: § 50.24(a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall
p.000114: provide this in- formation in writing to FDA, inves- tigators who are asked to participate in this
p.000114: or a substantially equivalent clinical investigation, and other IRB’s that are asked to review this or
p.000114: a sub- stantially equivalent investigation.
p.000114: [61 FR 51531, Oct. 2, 1996, as amended at 64 FR
p.000114: 10943, Mar. 8, 1999]
p.000114:
p.000114: Subpart D—IRB Review and Approval
p.000114: § 812.60 IRB composition, duties, and functions.
p.000114: An IRB reviewing and approving in- vestigations under this part shall com- ply with the requirements of part 56 in
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
...
p.000118: records that identify subjects, upon notice that FDA has reason to suspect that ade- quate informed consent
p.000118: was not ob- tained, or that reports required to be submitted by the investigator to the sponsor or
p.000118: IRB have not been sub- mitted or are incomplete, inaccurate, false, or misleading.
p.000118: § 812.150 Reports.
p.000118: (a) Investigator reports. An investi- gator shall prepare and submit the fol- lowing complete, accurate, and
p.000118: timely reports:
p.000118:
p.000118: (1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the
p.000118: reviewing IRB a re- port of any unanticipated adverse de- vice effect occurring during an inves- tigation
p.000118: as soon as possible, but in no event later than 10 working days after the investigator first learns of
p.000118: the ef- fect.
p.000118: (2) Withdra al of IRB approval. An in- vestigator shall report to the sponsor, within 5 working days, a
p.000118: withdrawal of approval by the reviewing IRB of the investigator’s part of an investigation.
p.000118: (3) Progress. An investigator shall submit progress reports on the inves- tigation to the sponsor,
p.000118: the monitor, and the reviewing IRB at regular inter- vals, but in no event less often than yearly.
p.000118: (4) Deviations from the investigational plan. An investigator shall notify the sponsor and the reviewing
p.000118: IRB (see
p.000118: § 56.108(a) (3) and (4)) of any deviation from the investigational plan to pro- tect the life or physical
p.000118: well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event
p.000118: later than 5 working days after the emergency occurred. Except in such an emergency, prior approval by
p.000118: the sponsor is required for changes in or deviations from a plan, and if these changes or
p.000118: deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human
p.000118: subjects, FDA and IRB in accordance with § 812.35(a) also is required.
p.000118: (5) Informed consent. If an investi- gator uses a device without obtaining informed consent, the
p.000118: investigator shall report such use to the sponsor and the reviewing IRB within 5 work- ing days after the
p.000118: use occurs.
p.000118: (6) Final report. An investigator shall, within 3 months after termination or completion of the investigation
p.000118: or the investigator’s part of the investigation, submit a final report to the sponsor and the reviewing IRB.
p.000118: (7) Other. An investigator shall, upon request by a reviewing IRB or FDA, provide accurate, complete,
p.000118: and cur- rent information about any aspect of the investigation.
p.000118: (b) Sponsor reports. A sponsor shall prepare and submit the following com- plete, accurate, and timely
p.000118: reports:
p.000119: 119
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119: Pt. 814
p.000119: (1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse
p.000119: device ef- fect under § 812.46(b) shall report the re- sults of such evaluation to FDA and to all reviewing IRB’s
p.000119: and participating investigators within 10 working days after the sponsor first receives notice of the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000102: 812.10 Waivers.
p.000102: 812.18 Import and export requirements.
p.000102: 812.19 Address for IDE correspondence.
p.000102:
p.000102: Subpart B—Application and Administrative Action
p.000102: 812.20 Application.
p.000102: 812.25 Investigational plan.
p.000102: 812.27 Report of prior investigations.
p.000102: 812.30 FDA action on applications.
p.000102: 812.35 Supplemental applications.
p.000102: 812.36 Treatment use of an investigational device.
p.000102: 812.38 Confidentiality of data and informa- tion.
p.000102:
p.000102: Subpart C—Responsibilities of Sponsors
p.000102: 812.40 General responsibilities of sponsors.
p.000102: 812.42 FDA and IRB approval.
p.000102: 812.43 Selecting investigators and monitors.
p.000102: 812.45 Informing investigators.
p.000102: 812.46 Monitoring investigations.
p.000102: 812.47 Emergency research under § 50.24 of this chapter.
p.000102:
p.000102: Subpart D—IRB Review and Approval
p.000102: 812.60 IRB composition, duties, and func- tions.
p.000102: 812.62 IRB approval.
p.000102: 812.64 IRB’s continuing review.
p.000102: 812.65 [Reserved]
p.000102: 812.66 Significant risk device determina- tions.
p.000102:
p.000102: Subpart E—Responsibilities of Investigators
p.000102: 812.100 General responsibilities of investiga- tors.
p.000102: 812.110 Specific responsibilities of investiga- tors.
p.000102: 812.119 Disqualification of a clinical investi- gator.
p.000102:
p.000102: Subpart F [Reserved]
p.000102: Subpart G—Records and Reports
p.000102: 812.140 Records.
p.000102: 812.145 Inspections.
p.000102: 812.150 Reports.
p.000102: AUTHORITY: 21 U.S.C. 331, 351, 352, 353, 355,
p.000102: 360, 360c–360f, 360h–360j, 371, 372, 374, 379e, 381,
p.000102: 382, 383; 42 U.S.C. 216, 241, 262, 263b–263n.
p.000102: SOURCE: 45 FR 3751, Jan. 18, 1980, unless
p.000102: otherwise noted.
p.000102: 102
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Food and Drug Administration, HHS § 812.2
p.000102:
p.000102: Subpart A—General Provisions
p.000102: § 812.1 Scope.
p.000102: (a) The purpose of this part is to en- courage, to the extent consistent with the protection of
p.000102: public health and safety and with ethical standards, the discovery and development of useful devices
p.000102: intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pur- suit of
p.000102: this purpose. This part provides procedures for the conduct of clinical investigations of devices. An approved
p.000102: investigational device exemption (IDE) permits a device that otherwise would be required to comply with a
p.000102: perform- ance standard or to have premarket ap- proval to be shipped lawfully for the purpose of conducting
p.000102: investigations of that device. An IDE approved under
p.000102: § 812.30 or considered approved under
p.000102: § 812.2(b) exempts a device from the re- quirements of the following sections of the Federal Food, Drug, and
p.000102: Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act,
...
p.000117: a cat- egory of investigation or a particular investigation.
p.000117: (c) IRB records. An IRB shall main- tain records in accordance with part 56 of this chapter.
p.000117: (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart
p.000117: during the in- vestigation and for a period of 2 years after the latter of the following two dates: The
p.000117: date on which the investiga- tion is terminated or completed, or the
p.000118: 118
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Food and Drug Administration, HHS § 812.150
p.000118:
p.000118:
p.000118: date that the records are no longer re- quired for purposes of supporting a pre- market approval application
p.000118: or a no- tice of completion of a product devel- opment protocol.
p.000118: (e) Records custody. An investigator or sponsor may withdraw from the re- sponsibility to maintain records
p.000118: for the period required in paragraph (d) of this section and transfer custody of the records to any other
p.000118: person who will accept responsibility for them under this part, including the requirements of § 812.145.
p.000118: Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
p.000118: [45 FR 3751, Jan. 18, 1980, as amended at 45
p.000118: FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27,
p.000118: 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb.
p.000118: 2, 1998]
p.000118:
p.000118: § 812.145 Inspections.
p.000118: (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit
p.000118: authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any
p.000118: establishment where devices are held (including any estab- lishment where devices are manufac- tured,
p.000118: processed, packed, installed, used, or implanted or where records of results from use of devices are kept).
p.000118: (b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such
p.000118: a person with respect to an investigation, shall per- mit authorized FDA employees, at rea- sonable times and in
p.000118: a reasonable man- ner, to inspect and copy all records re- lating to an investigation.
p.000118: (c) Records identifying subjects. An in- vestigator shall permit authorized FDA employees to inspect and copy
p.000118: records that identify subjects, upon notice that FDA has reason to suspect that ade- quate informed consent
p.000118: was not ob- tained, or that reports required to be submitted by the investigator to the sponsor or
p.000118: IRB have not been sub- mitted or are incomplete, inaccurate, false, or misleading.
p.000118: § 812.150 Reports.
p.000118: (a) Investigator reports. An investi- gator shall prepare and submit the fol- lowing complete, accurate, and
p.000118: timely reports:
p.000118:
p.000118: (1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the
...
Orphaned Trigger Words
p.000106: IDE (or an IDE applica- tion).’’
p.000106: [71 FR 42048, July 25, 2006, as amended at 75
p.000106: FR 20915, Apr. 22, 2010]
p.000106: Subpart B—Application and Administrative Action
p.000106: § 812.20 Application.
p.000106: (a) Submission. (1) A sponsor shall submit an application to FDA if the sponsor intends to use
p.000106: a significant risk device in an investigation, intends to conduct an investigation that in- volves an
p.000106: exception from informed con- sent under § 50.24 of this chapter, or if FDA notifies the sponsor that an appli-
p.000106: cation is required for an investigation.
p.000106: (2) A sponsor shall not begin an in- vestigation for which FDA’s approval of an application is required
p.000106: until FDA has approved the application.
p.000106: (3) A sponsor shall submit three cop- ies of a signed ‘‘Application for an In- vestigational Device
p.000106: Exemption’’ (IDE application), together with accom- panying materials, by registered mail or by hand
p.000106: to the address in § 812.19. Subsequent correspondence concerning an application or a supplemental appli- cation
p.000106: shall be submitted by registered mail or by hand.
p.000106: (4)(i) A sponsor shall submit a sepa- rate IDE for any clinical investigation involving an exception from
p.000106: informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to
p.000106: proceed without the prior written authorization of FDA. FDA shall provide a written determination 30 days
p.000106: after FDA receives the IDE or earlier.
p.000106: (ii) If the investigation involves an exception from informed consent under
p.000106: § 50.24 of this chapter, the sponsor shall prominently identify on the cover sheet that the
p.000106: investigation is subject to the requirements in § 50.24 of this chapter.
p.000106: (b) Contents. An IDE application shall include, in the following order:
p.000106: (1) The name and address of the spon- sor.
p.000106: (2) A complete report of prior inves- tigations of the device and an accurate summary of those sections of the
p.000106: inves- tigational plan described in § 812.25(a) through (e) or, in lieu of the summary, the complete plan. The
p.000106: sponsor shall submit to FDA a complete investiga- tional plan and a complete report of prior
p.000106: investigations of the device if no IRB has reviewed them, if FDA has
p.000107: 107
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: § 812.25
p.000107: found an IRB’s review inadequate, or if FDA requests them.
p.000107: (3) A description of the methods, fa- cilities, and controls used for the man- ufacture, processing, packing,
p.000107: storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally
p.000107: familiar with good manufacturing practices can make a knowledgeable judgment about the quality
p.000107: control used in the manufac- ture of the device.
p.000107: (4) An example of the agreements to be entered into by all investigators to comply with investigator
p.000107: obligations under this part, and a list of the names and addresses of all investigators who have signed the
p.000107: agreement.
p.000107: (5) A certification that all investiga- tors who will participate in the inves- tigation have signed
...
p.000108: justify failure to provide information on a relevant nonclinical test study.
p.000108: [45 FR 3751, Jan. 18, 1980, as amended at 50
p.000108: FR 7518, Feb. 22, 1985]
p.000108: § 812.30 FDA action on applications.
p.000108: (a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an
p.000108: application. FDA may approve an investigation as pro- posed, approve it with modifications,
p.000108:
p.000108: or disapprove it. An investigation may not begin until:
p.000108: (1) Thirty days after FDA receives the application at the address in § 812.19 for the investigation of a
p.000108: device other than a banned device, unless FDA noti- fies the sponsor that the investigation may not begin; or
p.000108: (2) FDA approves, by order, an IDE for the investigation.
p.000108: (b) Grounds for disapproval or ith- dra al. FDA may disapprove or with- draw approval of an
p.000108: application if FDA finds that:
p.000108: (1) There has been a failure to comply with any requirement of this part or the act, any other applicable
p.000108: regula- tion or statute, or any condition of ap- proval imposed by an IRB or FDA.
p.000108: (2) The application or a report con- tains an untrue statement of a mate- rial fact, or omits material
p.000108: informa- tion required by this part.
p.000108: (3) The sponsor fails to respond to a request for additional information within the time prescribed
p.000108: by FDA.
p.000108: (4) There is reason to believe that the risks to the subjects are not out- weighed by the anticipated
p.000108: benefits to the subjects and the importance of the knowledge to be gained, or informed consent is
p.000108: inadquate, or the investiga- tion is scientifically unsound, or there is reason to believe that the
p.000108: device as used is ineffective.
p.000108: (5) It is otherwise unreasonable to begin or to continue the investigation owing to the way in which the
p.000108: device is used or the inadequacy of:
p.000108: (i) The report of prior investigations or the investigational plan;
p.000108: (ii) The methods, facilities, and con- trols used for the manufacturing, proc- essing, packaging, storage, and,
p.000108: where appropriate, installation of the device; or
p.000108: (iii) Monitoring and review of the in- vestigation.
p.000108: (c) Notice of disapproval or ithdra al. If FDA disapproves an application or proposes to withdraw
p.000108: approval of an application, FDA will notify the spon- sor in writing.
p.000108: (1) A disapproval order will contain a complete statement of the reasons for disapproval and a statement that
p.000108: the sponsor has an opportunity to request a hearing under part 16.
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: § 812.35
p.000109: (2) A notice of a proposed withdrawal of approval will contain a complete statement of the reasons
p.000109: for with- drawal and a statement that the spon- sor has an opportunity to request a hearing under
p.000109: part 16. FDA will provide the opportunity for hearing before withdrawal of approval, unless FDA de-
p.000109: termines in the notice that continu- ation of testing under the exemption will result in an unreasonble
p.000109: risk to the public health and orders with- drawal of approval before any hearing.
...
p.000109: case of a deviation from the investigational plan to protect the life or physical well-being of a
p.000109: subject in an emer- gency. Such deviation shall be reported to FDA within 5-working days after the sponsor
p.000109: learns of it (see § 812.150(a)(4)).
p.000109: (3) Changes effected ith notice to FDA ithin 5 days. A sponsor may make cer- tain changes without prior
p.000109: approval of a supplemental application under para- graph (a)(1) of this section if the spon- sor determines
p.000109: that these changes meet the criteria described in para-
p.000109: graphs (a)(3)(i) and (a)(3)(ii) of this sec- tion, on the basis of credible informa- tion defined in paragraph
p.000109: (a)(3)(iii) of this section, and the sponsor provides notice to FDA within 5-working days of making these
p.000109: changes.
p.000109: (i) Developmental changes. The re- quirements in paragraph (a)(1) of this section regarding FDA
p.000109: approval of a
p.000109: 21 CFR Ch. I (4–1–11 Edition)
p.000109: supplement do not apply to develop- mental changes in the device (includ- ing manufacturing changes)
p.000109: that do not constitute a significant change in design or basic principles of operation and that are made
p.000109: in response to infor- mation gathered during the course of an investigation.
p.000109: (ii) Changes to clinical protocol. The requirements in paragraph (a)(1) of this section regarding FDA
p.000109: approval of a supplement do not apply to changes to clinical protocols that do not affect:
p.000109: (A) The validity of the data or infor- mation resulting from the completion of the approved protocol, or
p.000109: the rela- tionship of likely patient risk to ben- efit relied upon to approve the pro- tocol;
p.000109: (B) The scientific soundness of the in- vestigational plan; or
p.000109: (C) The rights, safety, or welfare of the human subjects involved in the in- vestigation.
p.000109: (iii) Definition of credible information.
p.000109: (A) Credible information to support de- velopmental changes in the device (in- cluding manufacturing
p.000109: changes) in- cludes data generated under the design control procedures of § 820.30, pre- clinical/animal
p.000109: testing, peer reviewed published literature, or other reliable information such as clinical informa- tion
p.000109: gathered during a trial or mar- keting.
p.000109: (B) Credible information to support changes to clinical protocols is defined as the sponsor’s documentation
p.000109: sup- porting the conclusion that a change does not have a significant impact on the study design or
p.000109: planned statistical analysis, and that the change does not affect the rights, safety, or welfare of the
p.000109: subjects. Documentation shall in- clude information such as peer re- viewed published literature,
p.000109: the rec- ommendation of the clinical investi- gator(s), and/or the data gathered dur- ing the clinical
p.000109: trial or marketing.
p.000109: (iv) Notice of IDE change. Changes meeting the criteria in paragraphs (a)(3)(i) and
p.000109: (a)(3)(ii) of this section that are supported by credible informa-
p.000109: tion as defined in paragraph (a)(3)(iii) of this section may be made without prior FDA approval if the
...
p.000111: (b) Criteria. FDA shall consider the
p.000111: use of an investigational device under a treatment IDE if:
p.000111: (1) The device is intended to treat or diagnose a serious or immediately life- threatening disease or condition;
p.000111: (2) There is no comparable or satis- factory alternative device or other therapy available to
p.000111: treat or diagnose that stage of the disease or condition in the intended patient population;
p.000111: (3) The device is under investigation in a controlled clinical trial for the same use under an
p.000111: approved IDE, or such clinical trials have been com- pleted; and
p.000111: (4) The sponsor of the investigation is actively pursuing marketing approval/ clearance of the investigational
p.000111: device with due diligence.
p.000111: (c) Applications for treatment use. (1) A treatment IDE application shall in- clude, in the following
p.000111: order:
p.000111: (i) The name, address, and telephone number of the sponsor of the treatment IDE;
p.000111: (ii) The intended use of the device, the criteria for patient selection, and a written protocol describing the
p.000111: treat- ment use;
p.000111: (iii) An explanation of the rationale for use of the device, including, as ap- propriate, either a list
p.000111: of the available regimens that ordinarily should be tried before using the investigational device or
p.000111: an explanation of why the use of the investigational device is pref-
p.000111: 21 CFR Ch. I (4–1–11 Edition)
p.000111: erable to the use of available marketed treatments;
p.000111: (iv) A description of clinical proce- dures, laboratory tests, or other meas- ures that will be used to
p.000111: evaluate the effects of the device and to minimize risk;
p.000111: (v) Written procedures for moni- toring the treatment use and the name and address of the monitor;
p.000111: (vi) Instructions for use for the de- vice and all other labeling as required under § 812.5(a) and (b);
p.000111: (vii) Information that is relevant to the safety and effectiveness of the de- vice for the intended
p.000111: treatment use. In- formation from other IDE’s may be in- corporated by reference to support the treatment use;
p.000111: (viii) A statement of the sponsor’s commitment to meet all applicable re- sponsibilities under this
p.000111: part and part 56 of this chapter and to ensure compli- ance of all participating investigators with the
p.000111: informed consent require- ments of part 50 of this chapter;
p.000111: (ix) An example of the agreement to be signed by all investigators partici- pating in the treatment IDE
p.000111: and cer- tification that no investigator will be added to the treatment IDE before the agreement is signed;
p.000111: and
p.000111: (x) If the device is to be sold, the price to be charged and a statement in- dicating that the price is
p.000111: based on manufacturing and handling costs only.
p.000111: (2) A licensed practitioner who re- ceives an investigational device for treatment use under a
p.000111: treatment IDE is an ‘‘investigator’’ under the IDE and is responsible for meeting all applica- ble investigator
p.000111: responsibilities under this part and parts 50 and 56 of this chapter.
p.000111: (d) FDA action on treatment IDE appli- cations—(1) Approval of treatment IDE’s. Treatment use may begin 30
p.000111: days after FDA receives the treatment IDE sub- mission at the address specified in
...
p.000114: cannot ap- prove the research because it does not meet the criteria in the exception in
p.000114: § 50.24(a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall
p.000114: provide this in- formation in writing to FDA, inves- tigators who are asked to participate in this
p.000114: or a substantially equivalent clinical investigation, and other IRB’s that are asked to review this or
p.000114: a sub- stantially equivalent investigation.
p.000114: [61 FR 51531, Oct. 2, 1996, as amended at 64 FR
p.000114: 10943, Mar. 8, 1999]
p.000114:
p.000114: Subpart D—IRB Review and Approval
p.000114: § 812.60 IRB composition, duties, and functions.
p.000114: An IRB reviewing and approving in- vestigations under this part shall com- ply with the requirements of part 56 in
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115:
p.000115: § 812.62
p.000115: all respects, including its composition, duties, and functions.
p.000115: [46 FR 8957, Jan. 27, 1981]
p.000115: § 812.62 IRB approval.
p.000115: (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure
p.000115: approval), or dis- approve all investigations covered by this part.
p.000115: (b) If no IRB exists or if FDA finds that an IRB’s review is inadequate, a sponsor may submit an
p.000115: application to FDA.
p.000115: [46 FR 8957, Jan. 27, 1981]
p.000115: § 812.64 IRB’s continuing review.
p.000115: The IRB shall conduct its continuing review of an investigation in accord- ance with part 56.
p.000115: [46 FR 8957, Jan. 27, 1981]
p.000115: § 812.65 [Reserved]
p.000115: § 812.66 Significant risk device deter- minations.
p.000115: If an IRB determines that an inves- tigation, presented for approval under
p.000115: § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the inves- tigator and, where
p.000115: appropriate, the sponsor. A sponsor may not begin the investigation except as provided in
p.000115: § 812.30(a).
p.000115: [46 FR 8957, Jan. 27, 1981]
p.000115:
p.000115: Subpart E—Responsibilities of Investigators
p.000115: § 812.100 General responsibilities of in- vestigators.
p.000115: An investigator is responsible for en- suring that an investigation is con- ducted according to the
p.000115: signed agree- ment, the investigational plan and ap- plicable FDA regulations, for pro- tecting the
p.000115: rights, safety, and welfare of subjects under the investigator’s care, and for the control of
p.000115: devices under investigation. An investigator also is responsible for ensuring that in- formed consent is
p.000115: obtained in accord- ance with part 50 of this chapter. Addi- tional responsibilities of investigators are
p.000115: described in subpart G.
p.000115: [45 FR 3751, Jan. 18, 1980, as amended at 46
p.000115: FR 8957, Jan. 27, 1981]
p.000115: 21 CFR Ch. I (4–1–11 Edition)
p.000115:
p.000115: § 812.110 Specific responsibilities of in- vestigators.
p.000115: (a) A aiting approval. An investigator may determine whether potential sub- jects would be interested in
p.000115: partici- pating in an investigation, but shall not request the written informed con- sent of any
p.000115: subject to participate, and shall not allow any subject to partici- pate before obtaining IRB and FDA ap-
p.000115: proval.
p.000115: (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with
p.000115: the sponsor, the investigational plan, this part and other applicable FDA regula- tions, and any
p.000115: conditions of approval imposed by an IRB or FDA.
p.000115: (c) Supervising device use. An investi- gator shall permit an investigational device to be used only with
p.000115: subjects under the investigator’s supervision. An investigator shall not supply an in- vestigational device to
p.000115: any person not authorized under this part to receive it.
p.000115: (d) Financial disclosure. A clinical in- vestigator shall disclose to the sponsor sufficient accurate financial
p.000115: informa- tion to allow the applicant to submit complete and accurate certification or disclosure statements
p.000115: required under part 54 of this chapter. The investi- gator shall promptly update this infor- mation if
p.000115: any relevant changes occur during the course of the investigation and for 1 year following completion of
...
p.000116: act.
p.000116: (f) An investigator who has been de- termined to be ineligible to receive in- vestigational devices
p.000116: may be rein- stated as eligible when the Commis- sioner determines that the investigator has presented
p.000116: adequate assurances that the investigator will employ investiga- tional devices solely in compliance with the
p.000116: provisions of this part and of parts 50 and 56 of this chapter.
p.000116: [62 FR 12096, Mar. 14, 1997, as amended at 71
p.000116: FR 76902, Dec. 22, 2006]
p.000116:
p.000116: Subpart F [Reserved]
p.000116: Subpart G—Records and Reports
p.000116: § 812.140 Records.
p.000116: (a) Investigator records. A partici- pating investigator shall maintain the following accurate,
p.000116: complete, and cur- rent records relating to the investiga- tor’s participation in an investigation:
p.000116: (1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including
p.000116: required reports.
p.000116: (2) Records of receipt, use or disposi- tion of a device that relate to:
p.000116: (i) The type and quantity of the de- vice, the dates of its receipt, and the batch number or code mark.
p.000117: 117
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: § 812.140
p.000117: (ii) The names of all persons who re- ceived, used, or disposed of each device.
p.000117: (iii) Why and how many units of the device have been returned to the spon- sor, repaired, or otherwise
p.000117: disposed of.
p.000117: (3) Records of each subject’s case his- tory and exposure to the device. Case histories include the case
p.000117: report forms and supporting data including, for ex- ample, signed and dated consent forms and medical
p.000117: records including, for ex- ample, progress notes of the physician, the individual’s hospital chart(s), and the
p.000117: nurses’ notes. Such records shall include:
p.000117: (i) Documents evidencing informed consent and, for any use of a device by the investigator without informed con-
p.000117: sent, any written concurrence of a li- censed physician and a brief descrip- tion of the circumstances
p.000117: justifying the failure to obtain informed consent. The case history for each individual shall document
p.000117: that informed consent was obtained prior to participation in the study.
p.000117: (ii) All relevant observations, includ- ing records concerning adverse device effects (whether anticipated or
p.000117: unan- ticipated), information and data on the condition of each subject upon enter- ing, and during the course
p.000117: of, the in- vestigation, including information about relevant previous medical his- tory and the
p.000117: results of all diagnostic tests.
p.000117: (iii) A record of the exposure of each subject to the investigational device, including the date and
p.000117: time of each use, and any other therapy.
p.000117: (4) The protocol, with documents showing the dates of and reasons for each deviation from the protocol.
p.000117: (5) Any other records that FDA re- quires to be maintained by regulation or by specific requirement for
p.000117: a cat- egory of investigations or a particular investigation.
p.000117: (b) Sponsor records. A sponsor shall maintain the following accurate, com- plete, and current records
p.000117: relating to an investigation:
p.000117: (1) All correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA, including required
p.000117: re- ports.
p.000117: (2) Records of shipment and disposi- tion. Records of shipment shall include the name and address of the
p.000117: consignee,
p.000117: 21 CFR Ch. I (4–1–11 Edition)
p.000117: type and quantity of device, date of shipment, and batch number or code mark. Records of
p.000117: disposition shall de- scribe the batch number or code marks of any devices returned to the sponsor, repaired, or
p.000117: disposed of in other ways by the investigator or another person, and the reasons for and method of dis-
p.000117: posal.
...
p.000118: reports:
p.000119: 119
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000119: Pt. 814
p.000119: (1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse
p.000119: device ef- fect under § 812.46(b) shall report the re- sults of such evaluation to FDA and to all reviewing IRB’s
p.000119: and participating investigators within 10 working days after the sponsor first receives notice of the
p.000119: effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA
p.000119: requests.
p.000119: (2) Withdra al of IRB approval. A sponsor shall notify FDA and all re- viewing IRB’s and
p.000119: participating inves- tigators of any withdrawal of approval of an investigation or a part of an in-
p.000119: vestigation by a reviewing IRB within
p.000119: 5 working days after receipt of the withdrawal of approval.
p.000119: (3) Withdra al of FDA approval. A sponsor shall notify all reviewing IRB’s and participating
p.000119: investigators of any withdrawal of FDA approval of the in- vestigation, and shall do so within 5 working
p.000119: days after receipt of notice of the withdrawal of approval.
p.000119: (4) Current investigator list. A sponsor shall submit to FDA, at 6-month inter- vals, a current list of the
p.000119: names and addresses of all investigators partici- pating in the investigation. The spon- sor shall submit
p.000119: the first such list 6 months after FDA approval.
p.000119: (5) Progress reports. At regular inter- vals, and at least yearly, a sponsor shall submit progress
p.000119: reports to all re- viewing IRB’s. In the case of a signifi- cant risk device, a sponsor shall also
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Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| drug | Drug Usage |
| emergency | Public Emergency |
| employees | employees |
| freedomXofXinformation | Access to information |
| home | Property Ownership |
| ill | ill |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| minor | Youth/Minors |
| nation | stateless persons |
| native | Indigenous |
| property | Property Ownership |
| restricted | Incarcerated |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| home | ['property'] |
| property | ['home'] |
Trigger Words
consent
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input