Title 21

PART 812

Part 812 - Investigational Device Exemptions

PART 812 - INVESTIGATIONAL DEVICE EXEMPTIONS Authority:21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n. Source:45 FR 3751, Jan. 18, 1980, unless otherwise noted.

• Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
• Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

21:8.0.1.1.9.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.9.1.1.1	SECTION 812.1	812.1 Scope.
21:8.0.1.1.9.1.1.2	SECTION 812.2	812.2 Applicability.
21:8.0.1.1.9.1.1.3	SECTION 812.3	812.3 Definitions.
21:8.0.1.1.9.1.1.4	SECTION 812.5	812.5 Labeling of investigational devices.
21:8.0.1.1.9.1.1.5	SECTION 812.7	812.7 Prohibition of promotion and other practices.
21:8.0.1.1.9.1.1.6	SECTION 812.10	812.10 Waivers.
21:8.0.1.1.9.1.1.7	SECTION 812.18	812.18 Import and export requirements.
21:8.0.1.1.9.1.1.8	SECTION 812.19	812.19 Address for IDE correspondence.
21:8.0.1.1.9.2	SUBPART B	Subpart B - Application and Administrative Action
21:8.0.1.1.9.2.1.1	SECTION 812.20	812.20 Application.
21:8.0.1.1.9.2.1.2	SECTION 812.25	812.25 Investigational plan.
21:8.0.1.1.9.2.1.3	SECTION 812.27	812.27 Report of prior investigations.
21:8.0.1.1.9.2.1.4	SECTION 812.28	812.28 Acceptance of data from clinical investigations conducted outside the United States.
21:8.0.1.1.9.2.1.5	SECTION 812.30	812.30 FDA action on applications.
21:8.0.1.1.9.2.1.6	SECTION 812.35	812.35 Supplemental applications.
21:8.0.1.1.9.2.1.7	SECTION 812.36	812.36 Treatment use of an investigational device.
21:8.0.1.1.9.2.1.8	SECTION 812.38	812.38 Confidentiality of data and information.
21:8.0.1.1.9.3	SUBPART C	Subpart C - Responsibilities of Sponsors
21:8.0.1.1.9.3.1.1	SECTION 812.40	812.40 General responsibilities of sponsors.
21:8.0.1.1.9.3.1.2	SECTION 812.42	812.42 FDA and IRB approval.
21:8.0.1.1.9.3.1.3	SECTION 812.43	812.43 Selecting investigators and monitors.
21:8.0.1.1.9.3.1.4	SECTION 812.45	812.45 Informing investigators.
21:8.0.1.1.9.3.1.5	SECTION 812.46	812.46 Monitoring investigations.
21:8.0.1.1.9.3.1.6	SECTION 812.47	812.47 Emergency research under § 50.24 of this chapter.
21:8.0.1.1.9.4	SUBPART D	Subpart D - IRB Review and Approval
21:8.0.1.1.9.4.1.1	SECTION 812.60	812.60 IRB composition, duties, and functions.
21:8.0.1.1.9.4.1.2	SECTION 812.62	812.62 IRB approval.
21:8.0.1.1.9.4.1.3	SECTION 812.64	812.64 IRB's continuing review.
21:8.0.1.1.9.4.1.4	SECTION 812.65	812.65 [Reserved]
21:8.0.1.1.9.4.1.5	SECTION 812.66	812.66 Significant risk device determinations.
21:8.0.1.1.9.5	SUBPART E	Subpart E - Responsibilities of Investigators
21:8.0.1.1.9.5.1.1	SECTION 812.100	812.100 General responsibilities of investigators.
21:8.0.1.1.9.5.1.2	SECTION 812.110	812.110 Specific responsibilities of investigators.
21:8.0.1.1.9.5.1.3	SECTION 812.119	812.119 Disqualification of a clinical investigator.
21:8.0.1.1.9.6	SUBPART F	Subpart F [Reserved]
21:8.0.1.1.9.7	SUBPART G	Subpart G - Records and Reports
21:8.0.1.1.9.7.1.1	SECTION 812.140	812.140 Records.
21:8.0.1.1.9.7.1.2	SECTION 812.145	812.145 Inspections.
21:8.0.1.1.9.7.1.3	SECTION 812.150	812.150 Reports.

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