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FDA 21

21 CFR Part 814

Premarket Approval of Medical Devices
United StatesFDARegistration
What this code is

21 CFR Part 814 is the official FDA identifier for “Premarket Approval of Medical Devices”. 21 CFR Part 814 is the official identifier FDA uses for this instrument.

Instrument
21
Full name
21 CFR Part 814
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Registration
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English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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33 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
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About this regulation

Premarket Approval of Medical Devices

Current eCFR Part 814 premarket approval procedures.

21 CFR Part 814 is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.