Code of Federal Regulations · Subpart

Subpart E — Premarket Notification Procedures

21 C.F.R. pt. 807, subpt. E

• § 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