21 CFR Part 807
PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
- PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 807.3 Definitions.
- Subpart B—Procedures for Device Establishments
- § 807.20 Who must register and submit a device list?
- § 807.21 How to register establishments and list devices.
- § 807.22 Times for establishment registration and device listing.
- § 807.25 Information required for device establishment registration and device listing.
- § 807.26 Additional listing information.
- § 807.28 Updating device listing information.
- § 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
- § 807.35 Notification of registrant.
- § 807.37 Public availability of establishment registration and device listing information.
- § 807.39 Misbranding by reference to establishment registration or to registration number.
- Subpart C—Procedures for Foreign Device Establishments
- § 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
- § 807.41 Identification of importers and persons who import or offer for import.
- Subpart D—Exemptions
- § 807.65 Exemptions for device establishments.
- 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.
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