21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
- Subpart A - General (§§ 814.1 - 814.19)
- Subpart B - Premarket Approval Application (PMA) (§§ 814.20 - 814.39)
- Subpart C - FDA Action on a PMA (§§ 814.40 - 814.47)
- Subpart D - Administrative Review [Reserved]
- Subpart E - Postapproval Requirements (§§ 814.80 - 814.84)
- Subparts F-G [Reserved]
- Subpart H - Humanitarian Use Devices (§§ 814.100 - 814.126)
{'United States Code': [{'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': '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': '360g', 'headtext': ' Judicial review', 'cleanpath': '/uscode/text/21/360g'}, {'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': '373', 'headtext': ' Records', 'cleanpath': '/uscode/text/21/373'}, {'Title': '21', 'Section': '374', 'headtext': ' Inspection', 'cleanpath': '/uscode/text/21/374'}, {'Title': '21', 'Section': '374a', 'headtext': ' Inspections relating to food allergens', 'cleanpath': '/uscode/text/21/374a'}, {'Title': '21', 'Section': '375', 'headtext': ' Publicity', 'cleanpath': '/uscode/text/21/375'}, {'Title': '21', 'Section': '379', 'headtext': ' Confidential information', 'cleanpath': '/uscode/text/21/379'}, {'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': '5', 'Section': '552', 'headtext': ' Public information; agency rules, opinions, orders, records, and proceedings', 'cleanpath': '/uscode/text/5/552'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}