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21 CFR Part 801 · Labeling

§ 801.40 Form of a unique device identifier

Subpart B - Labeling Requirements for Unique Device Identification Official text on eCFR Amendment history

(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter . The UDI must be presented in two forms:

(1) Easily readable plain-text, and

(2) Automatic identification and data capture (AIDC) technology.

(b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by § 1271.290(c) of this chapter , the UDI must include a production identifier segment that conveys such information.

(c) If the AIDC technology is not evident upon visual examination of the label or device package, the label or device package must disclose the presence of AIDC technology.

(d) A class I device that bears a Universal Product Code (UPC) on its label and device packages is deemed to meet all requirements of subpart B of this part . The UPC will serve as the unique device identifier required by § 801.20 .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 801.40

Form FDA 483 observations citing this section, fiscal years 2024–2026 (Devices).

  • Form of a unique device identifier 7

Warning letters citing § 801.40

15 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 801.40

Amendment history

Federal Register documents that created or amended this section.