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21 CFR 801.20

Label to bear a unique device identifier. This section left the CFR when the QMSR took effect on Feb 2, 2026; the text below is as of Feb 1, 2026.

  • Inspections citing it: 126
  • Of those classified, ended OAI: 17%
  • Last cited: FY2026

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

Regulation Text

eCFR, as of Feb 1, 2026

(a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.

(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.

(b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.

Open 21 CFR 801.20 on eCFR

Recently Cited Sites

Newest inspections citing this section; each opens the site

Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR

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