21 CFR 801.40: Form of a unique device identifier
Requires device UDIs to appear in both plain text and AIDC form, include a device identifier plus production identifiers when labeled, disclose non-obvious AIDC, and treat UPCs on class I devices as compliant.
Part 801, Labeling · Subpart B, Labeling Requirements for Unique Device Identification
Recent 483s citing 801.40
- Automated Ophthalmics, Inc. · Elkridge, MarylandThe medical device(s) label did not have a unique device identifier (UDI) present… Feb 13, 2026
- Form 483 · FEI 3002619777 · Eagan, MinnesotaThe medical device(s) label did not have a unique device identifier (UDI) present… Feb 9, 2026
- APEX DENTAL SLEEP LAB LLC · La Mesa, CaliforniaThe medical device(s) label did not have a unique device identifier (UDI) present… Feb 22, 2024
The regulation text
§ 801.40 Form of a unique device identifier.
(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.
[78 FR 58818, Sept. 24, 2013]
Questions
What does 21 CFR 801.40 require?
Requires device UDIs to appear in both plain text and AIDC form, include a device identifier plus production identifiers when labeled, disclose non-obvious AIDC, and treat UPCs on class I devices as compliant.
Which sections are cited alongside 801.40?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.90 (Nonconforming product), 830.300 (Devices subject to device identification data submission requirements).