21 CFR Subpart E - Subpart E—Premarket Notification Procedures
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- § 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.