21 CFR 830.360

§ 830.360 Records to be maintained by the labeler.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 830.360, § 830.360 Records to be maintained by the labeler, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88989
Permanent ID: ys:prov:88989@1
SHA-256: 845432f6b016bd359f8e8781ed3bce566624a022cc72d7c5427eb2f8756a8794

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Full text

(a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 years from the date the labeler ceases to market the version or model. (b) Compliance with this section does not relieve the labeler of the need to comply with recordkeeping requirements of any other FDA regulation.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.