§ 801.20 Label to bear a unique device identifier.

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Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 801—LABELING > Subpart B—Labeling Requirements for Unique Device Identification

This text was captured on Sep 22, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

(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.

[78 FR 58818, Sept. 24, 2013]

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