Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.
Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.
Sections
- § 807.3 Definitions.
- § 807.20 Who must register and submit a device list?
- § 807.21 How to register establishments and list devices.
- § 807.22 Times for establishment registration and device listing.
- § 807.25 Information required for device establishment registration and device listing.
- § 807.26 Additional listing information.
- § 807.28 Updating device listing information.
- § 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
- § 807.35 Notification of registrant.
- § 807.37 Public availability of establishment registration and device listing information.
- § 807.39 Misbranding by reference to establishment registration or to registration number.
- § 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
- § 807.41 Identification of importers and persons who import or offer for import.
- § 807.65 Exemptions for device establishments.
- § 807.81 When a premarket notification submission is required.
- § 807.85 Exemption from premarket notification.
- § 807.87 Information required in a premarket notification submission.
- § 807.90 Format of a premarket notification submission.
- § 807.92 Content and format of a 510(k) summary.
- § 807.93 Content and format of a 510(k) statement.
- § 807.94 Format of a class III certification.
- § 807.95 Confidentiality of information.
- § 807.97 Misbranding by reference to premarket notification.
- § 807.100 FDA action on a premarket notification.