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.

• 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.

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

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