FDA 21 CFR Part 807 Establishment Registration and Device Listing For Manufacturers and Initial Importers Of Devices:
Table of contents
Subpart A - General Provisions
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.
807.35 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
807.41 Identification of importers and persons who import or offer for import.
Subpart E - Premarket Notification Procedures
FDA 21 CFR Part 807 Establishment Registration and Device Listing For Manufacturers and Initial Importers Of Devices:
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