CFR /  Title 21  /  Part 807: Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices

Section No.	Description
Section 807.3	Who must register and submit a device list?
Section 807.20	How to register establishments and list devices
Section 807.21	Times for establishment registration and device listing
Section 807.22	Information required for device establishment registration and device listing
Section 807.25	Additional listing information
Section 807.26	Updating device listing information
Section 807.28	Summary of requirements for owners or operators granted a waiver from submitting required information electronically
Section 807.34	Notification of registrant
Section 807.35	Public availability of establishment registration and device listing information
Section 807.37	Misbranding by reference to establishment registration or to registration number
Section 807.39	Establishment registration and device listing for foreign establishments importing or offering for import devices
Section 807.40	Identification of importers and persons who import or offer for import
Section 807.41	Exemptions for device establishments
Section 807.65	When a premarket notification submission is required
Section 807.81	Exemption from premarket notification
Section 807.85	Information required in a premarket notification submission
Section 807.87	Format of a premarket notification submission
Section 807.90	Content and format of a 510(k) summary
Section 807.92	Content and format of a 510(k) statement
Section 807.93	Format of a class III certification
Section 807.94	Confidentiality of information
Section 807.95	Misbranding by reference to premarket notification
Section 807.97	FDA action on a premarket notification
Section 807.100	Scope