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  1. Unique Device Identification System (UDI System)

UDI Exceptions and Alternatives

The UDI rule provides a method for labelers to request exceptions and alternatives to UDI requirements.

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Exceptions and Alternatives Granted by FDA

Under to 21 CFR 801.55(c), any labeler may make use of an exception or alternative granted under § 801.55, provided that such use satisfies all safeguards or conditions that are part of the FDA exception or alternative decision.

Labelers should refer to the information in the table below, especially in the "FDA Decision" column, to determine if an exception or alternative listed may apply to their situation. Labelers may document the applicability and use of an exception/alternative in the device master record (DMR) as part of the labeling specifications required under 21 CFR 820.181(d) for each respective device, along with a copy of the applicable exception or alternative decision. 

FDA UDI Exception or Alternative Number Summary FDA Decision Expiration Date of Exception or Alternative Date of Posting
UDI-A160001 UPC - multiple product codes Decision 2023-09-24 2021-07-29
UDI-A160002 UPC - contact lens care Decision 2023-09-24 2021-07-29
UDI-A170001 Sterile inventory;
3-year exception;
21 CFR 801.30(a)(1)
Decision 2024-09-24: Class III;
2025-09-24: I/LS/LS;
2026-09-24: Class II
UDI-E140001 Soft (hydrophilic) contact lenses Decision One year after FDA:
1) develops and fully integrates the Technical Solution into the GUDID production system,
2) provides any necessary updated technical specifications to affected labelers, and
3) notifies industry that the extension will expire, through emails to industry, communication via trade associations, and via the UDI website.

Exceptions and Alternatives - General Information and How to Request

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