Subpart E - PREMARKET NOTIFICATION PROCEDURES
- 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