21 CFR
Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Subpart A - General Provisions
Subpart B - Procedures for Device Establishments
- § 807.20 Who must register and submit a device list? 6 × 483
- § 807.21 How to register establishments and list devices
- § 807.22 Times for establishment registration and device listing 3 × 483
- § 807.25 Information required for device establishment registration and device listing 1 × 483
- § 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
Subpart C - Procedures for Foreign Device Establishments
- § 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States 1 × 483
- § 807.41 Identification of importers and persons who import or offer for import
Subpart D - Exemptions
Subpart E - Premarket Notification Procedures
- § 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