Title 21

PART 807

Part 807 - Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices

PART 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Authority:21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 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.

21:8.0.1.1.5.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.5.1.1.1SECTION 807.3
   807.3 Definitions.
21:8.0.1.1.5.2SUBPART B
Subpart B - Procedures for Device Establishments
21:8.0.1.1.5.2.1.1SECTION 807.20
   807.20 Who must register and submit a device list
21:8.0.1.1.5.2.1.2SECTION 807.21
   807.21 How to register establishments and list devices.
21:8.0.1.1.5.2.1.3SECTION 807.22
   807.22 Times for establishment registration and device listing.
21:8.0.1.1.5.2.1.4SECTION 807.25
   807.25 Information required for device establishment registration and device listing.
21:8.0.1.1.5.2.1.5SECTION 807.26
   807.26 Additional listing information.
21:8.0.1.1.5.2.1.6SECTION 807.28
   807.28 Updating device listing information.
21:8.0.1.1.5.2.1.7SECTION 807.34
   807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
21:8.0.1.1.5.2.1.8SECTION 807.35
   807.35 Notification of registrant.
21:8.0.1.1.5.2.1.9SECTION 807.37
   807.37 Public availability of establishment registration and device listing information.
21:8.0.1.1.5.2.1.10SECTION 807.39
   807.39 Misbranding by reference to establishment registration or to registration number.
21:8.0.1.1.5.3SUBPART C
Subpart C - Procedures for Foreign Device Establishments
21:8.0.1.1.5.3.1.1SECTION 807.40
   807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
21:8.0.1.1.5.3.1.2SECTION 807.41
   807.41 Identification of importers and persons who import or offer for import.
21:8.0.1.1.5.4SUBPART D
Subpart D - Exemptions
21:8.0.1.1.5.4.1.1SECTION 807.65
   807.65 Exemptions for device establishments.
21:8.0.1.1.5.5SUBPART E
Subpart E - Premarket Notification Procedures
21:8.0.1.1.5.5.1.1SECTION 807.81
   807.81 When a premarket notification submission is required.
21:8.0.1.1.5.5.1.2SECTION 807.85
   807.85 Exemption from premarket notification.
21:8.0.1.1.5.5.1.3SECTION 807.87
   807.87 Information required in a premarket notification submission.
21:8.0.1.1.5.5.1.4SECTION 807.90
   807.90 Format of a premarket notification submission.
21:8.0.1.1.5.5.1.5SECTION 807.92
   807.92 Content and format of a 510(k) summary.
21:8.0.1.1.5.5.1.6SECTION 807.93
   807.93 Content and format of a 510(k) statement.
21:8.0.1.1.5.5.1.7SECTION 807.94
   807.94 Format of a class III certification.
21:8.0.1.1.5.5.1.8SECTION 807.95
   807.95 Confidentiality of information.
21:8.0.1.1.5.5.1.9SECTION 807.97
   807.97 Misbranding by reference to premarket notification.
21:8.0.1.1.5.5.1.10SECTION 807.100
   807.100 FDA action on a premarket notification.