Title 21, Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Definitions.

Who must register and submit a device list?

How to register establishments and list devices.

Times for establishment registration and device listing.

Information required for device establishment registration and device listing.

Additional listing information.

Updating device listing information.

Summary of requirements for owners or operators granted a waiver from submitting required information electronically.

Notification of registrant.

Public availability of establishment registration and device listing information.

Misbranding by reference to establishment registration or to registration number.

Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.

Identification of importers and persons who import or offer for import.

Exemptions for device establishments.

When a premarket notification submission is required.

Exemption from premarket notification.

Information required in a premarket notification submission.

Format of a premarket notification submission.

Content and format of a 510(k) summary.

Content and format of a 510(k) statement.

Format of a class III certification.

Confidentiality of information.

Misbranding by reference to premarket notification.

FDA action on a premarket notification.