21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
- Subpart A - General Provisions (§§ 812.1 - 812.19)
- Subpart B - Application and Administrative Action (§§ 812.20 - 812.38)
- Subpart C - Responsibilities of Sponsors (§§ 812.40 - 812.47)
- Subpart D - IRB Review and Approval (§§ 812.60 - 812.66)
- Subpart E - Responsibilities of Investigators (§§ 812.100 - 812.119)
- Subpart F [Reserved]
- Subpart G - Records and Reports (§§ 812.140 - 812.150)
{'United States Code': [{'Title': '42', 'Section': '216', 'headtext': ' Regulations', 'cleanpath': '/uscode/text/42/216'}, {'Title': '42', 'Section': '241', 'headtext': ' Research and investigations generally', 'cleanpath': '/uscode/text/42/241'}, {'Title': '42', 'Section': '262', 'headtext': ' Regulation of biological products', 'cleanpath': '/uscode/text/42/262'}, {'Title': '42', 'Section': '263b', 'headtext': ' Certification of mammography facilities', 'cleanpath': '/uscode/text/42/263b'}, {'Title': '42', 'Section': '263n', 'headtext': '', 'cleanpath': '/uscode/text/42/263n'}, {'Title': '21', 'Section': '331', 'headtext': ' Prohibited acts', 'cleanpath': '/uscode/text/21/331'}, {'Title': '21', 'Section': '351', 'headtext': ' Adulterated drugs and devices', 'cleanpath': '/uscode/text/21/351'}, {'Title': '21', 'Section': '352', 'headtext': ' Misbranded drugs and devices', 'cleanpath': '/uscode/text/21/352'}, {'Title': '21', 'Section': '353', 'headtext': ' Exemptions and consideration for certain drugs, devices, and biological products', 'cleanpath': '/uscode/text/21/353'}, {'Title': '21', 'Section': '355', 'headtext': ' New drugs', 'cleanpath': '/uscode/text/21/355'}, {'Title': '21', 'Section': '360', 'headtext': ' Registration of producers of drugs or devices', 'cleanpath': '/uscode/text/21/360'}, {'Title': '21', 'Section': '360c', 'headtext': ' Classification of devices intended for human use', 'cleanpath': '/uscode/text/21/360c'}, {'Title': '21', 'Section': '360d', 'headtext': ' Performance standards', 'cleanpath': '/uscode/text/21/360d'}, {'Title': '21', 'Section': '360e', 'headtext': ' Premarket approval', 'cleanpath': '/uscode/text/21/360e'}, {'Title': '21', 'Section': '360e-1', 'headtext': ' Pediatric uses of devices', 'cleanpath': '/uscode/text/21/360e-1'}, {'Title': '21', 'Section': '360f', 'headtext': ' Banned devices', 'cleanpath': '/uscode/text/21/360f'}, {'Title': '21', 'Section': '360h', 'headtext': ' Notification and other remedies', 'cleanpath': '/uscode/text/21/360h'}, {'Title': '21', 'Section': '360i', 'headtext': ' Records and reports on devices', 'cleanpath': '/uscode/text/21/360i'}, {'Title': '21', 'Section': '360j', 'headtext': ' General provisions respecting control of devices intended for human use', 'cleanpath': '/uscode/text/21/360j'}, {'Title': '21', 'Section': '360bbb-8b', 'headtext': ' Use of clinical investigation data from outside the United States', 'cleanpath': '/uscode/text/21/360bbb-8b'}, {'Title': '21', 'Section': '371', 'headtext': ' Regulations and hearings', 'cleanpath': '/uscode/text/21/371'}, {'Title': '21', 'Section': '372', 'headtext': ' Examinations and investigations', 'cleanpath': '/uscode/text/21/372'}, {'Title': '21', 'Section': '374', 'headtext': ' Inspection', 'cleanpath': '/uscode/text/21/374'}, {'Title': '21', 'Section': '379e', 'headtext': ' Listing and certification of color additives for foods, drugs, devices, and cosmetics', 'cleanpath': '/uscode/text/21/379e'}, {'Title': '21', 'Section': '381', 'headtext': ' Imports and exports', 'cleanpath': '/uscode/text/21/381'}, {'Title': '21', 'Section': '382', 'headtext': ' Exports of certain unapproved products', 'cleanpath': '/uscode/text/21/382'}, {'Title': '21', 'Section': '383', 'headtext': ' Office of International Relations', 'cleanpath': '/uscode/text/21/383'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}