21 CFR § 801.20 - Label to bear a unique device identifier.

---
identifier: "/us/cfr/t21/s801.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 801.20 - Label to bear a unique device identifier."
title_number: 21
title_name: "Food and Drugs"
section_number: "801.20"
section_name: "Label to bear a unique device identifier."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "801"
part_name: "LABELING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374."
regulatory_source: "41 FR 6896, Feb. 13, 1976, unless otherwise noted."
cfr_part: "801"
---


# 801.20 Label to bear a unique device identifier.

(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]