Premarket Notification Procedures

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  7. Premarket Notification Procedures

Checkout our iOS App for a better way to browser and research.

Section
807.81

When a premarket notification submission is required.

Section
807.85

Exemption from premarket notification.

Section
807.87

Information required in a premarket notification submission.

Section
807.90

Format of a premarket notification submission.

Section
807.92

Content and format of a 510(k) summary.

Section
807.93

Content and format of a 510(k) statement.

Section
807.94

Format of a class III certification.

Section
807.95

Confidentiality of information.

Section
807.97

Misbranding by reference to premarket notification.

Section
807.100

FDA action on a premarket notification.