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FDA 21

21 CFR Part 807 Subpart E

Premarket Notification Procedures
United StatesFDARegistration
What this code is

21 CFR Part 807 Subpart E is the official FDA identifier for “Premarket Notification Procedures”. 21 CFR Part 807 Subpart E is the official identifier FDA uses for this instrument.

Instrument
21
Full name
21 CFR Part 807 Subpart E
Category
Registration
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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Section view of 21 CFR Part 807
This metadata row is a virtual view. The official text is ingested once as 21 CFR Part 807.
Dates
Published
Effective
Consolidated through
2026-08-26
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Premarket Notification Procedures

Virtual view of Part 807 Subpart E (510(k) premarket notification). The official text is ingested once with Part 807.

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