Subpart E - Premarket Notification Procedures
- § 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