Title 21

PART 807 SUBPART 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.