FDA 21 CFR Part 807 Establishment Registration and Device Listing

FDA 21 CFR Part 807 Establishment Registration and Device Listing For Manufacturers and Initial Importers Of Devices:

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Table of contents

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 (and),

Subpart E - Premarket Notification Procedures

FDA 21 CFR Part 807 Establishment Registration and Device Listing For Manufacturers and Initial Importers Of Devices: