SUBPART E—Premarket Notification Procedures (§807.81 to §807.100)
- 807.81—When a premarket notification submission is required.
- 807.85—Exemption from premarket notification.
- 807.87—Information required in a premarket notification submission.
- 807.90—Format of a premarket notification submission.
- 807.92—Content and format of a 510(k) summary.
- 807.93—Content and format of a 510(k) statement.
- 807.94—Format of a class III certification.
- 807.95—Confidentiality of information.
- 807.97—Misbranding by reference to premarket notification.
- 807.100—FDA action on a premarket notification.