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?
- § 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.
Subpart C — Procedures for Foreign Device Establishments
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.