Subpart E—Premarket Notification Procedures

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3. Title 21
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5. Chapter I
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7. Part 807
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9. Subpart E

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 807.81
  § 807.81 When a premarket notification submission is required.
• 807.85
  § 807.85 Exemption from premarket notification.
• 807.87
  § 807.87 Information required in a premarket notification submission.
• 807.90
  § 807.90 Format of a premarket notification submission.
• 807.92
  § 807.92 Content and format of a 510(k) summary.
• 807.93
  § 807.93 Content and format of a 510(k) statement.
• 807.94
  § 807.94 Format of a class III certification.
• 807.95
  § 807.95 Confidentiality of information.
• 807.97
  § 807.97 Misbranding by reference to premarket notification.
• 807.100
  § 807.100 FDA action on a premarket notification.