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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS

21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

  • CFR
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  1. Subpart A—General Provisions (§§ 812.1 - 812.19)
  2. Subpart B—Application and Administrative Action (§§ 812.20 - 812.38)
  3. Subpart C—Responsibilities of Sponsors (§§ 812.40 - 812.47)
  4. Subpart D—IRB Review and Approval (§§ 812.60 - 812.66)
  5. Subpart E—Responsibilities of Investigators (§§ 812.100 - 812.119)
  6. Subpart F [Reserved]
  7. Subpart G—Records and Reports (§§ 812.140 - 812.150)
Authority:
21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.
Source:
45 FR 3751, Jan. 18, 1980, unless otherwise noted.

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