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  1. Unique Device Identification System (UDI System)

UDI Exceptions and Alternatives

October 19, 2022 Update: UPC Alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023. UDI Stakeholders: to help you understand what the expiration of these alternatives means for you, please read UPC Alternative UDI-A160001 and UDI-A160002 Questions and Answers.

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

On this page:

Exceptions and Alternatives Granted by the 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.

* For more information, read UPC Alternatives UDI-A160001 and UDI-A160002 Questions and Answers.

Exceptions and Alternatives - General Information and How to Request

General Questions and Answers on Time-Limited Alternatives

Since the publication of the UDI Rule in 2013, the FDA has granted time-limited alternative requests while labelers established or finalized internal processes and procedures needed to comply with UDI requirements. Below, we provide information about what it means for devices when the FDA does not extend a time-limited alternative.

Q1: What does it mean when a time-limited alternative expires?
A: Once a time-limited alternative expires, devices previously using the alternative must comply with applicable requirements of the UDI Rule, including adding the UDI to the device label and updating data in the Global Unique Device Identification Database. The FDA recommends consulting available guidance documents, in addition to the UDI Rule, to help understand applicable requirements.

The FDA does not object to the continued use of the alternative for finished devices that are manufactured and labeled prior to September 24, 2023. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative. 

Q2: If an alternative has not expired, can I still submit a request to use the alternative for products not currently under the specified alternative?
A: You may continue to submit requests for new products to be added to an alternative that has been granted before the alternative expires. Such devices may use the alternative until it expires.

For more information, please read Universal Product Codes (UPC) Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions.


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