Title 21

PART 807 SUBPART E

Subpart E - Premarket Notification Procedures

• 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.
• 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

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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