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