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FDA 21

21 CFR Part 807

Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
United StatesFDARegistration
What this code is

21 CFR Part 807 is the official FDA identifier for “Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices”. 21 CFR Part 807 is the official identifier FDA uses for this instrument.

Instrument
21
Full name
21 CFR Part 807
Category
Registration
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English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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24 articles · 1 language version
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About this regulation

Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Current eCFR Part 807 establishment registration, device listing, and premarket notification procedures. Subpart E is a virtual view of this same part.

21 CFR Part 807 is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.