UPC Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions
Questions and Answers Regarding September 24, 2023, Expiration of Alternatives UDI-A160001 and UDI-A160002
Q1: Alternatives UDI-A160001 and UDI-A160002 expire on September 24, 2023. What does that mean for devices that are using these alternatives?
A: 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. Once the alternative expires on September 24, 2023, devices previously using the alternative must comply with applicable requirements of the UDI Rule. Devices that do not currently have a unique device identifier (UDI) on their label and packages will need to add the UDI and update their data in the Global Unique Device Identification Database.
Q2: If I was using alternative UDI-A160001 or UDI-A160002, can I still have a Universal Product Code (UPC) on my label after September 24, 2023?
A: Yes. Under 21 CFR 801.35(b), a device may bear both a universal product code (UPC) and a UDI on its label and packages.
Q3: If I was using alternative UDI-A160001 or UDI-A160002, can I submit a request for an extension past September 24, 2023?
A: Under the UDI Rule, labelers may submit a request for alternative at any time. However, the FDA does not intend to grant additional extensions to alternatives UDI-A160001 and UDI-A160002 beyond September 24, 2023.
Q4: Can I still submit a request to use the UPC as an alternative to the UDI for devices not currently part of alternative UDI-A160001 or UDI-A160002?
A: You may continue to submit requests for new devices to be added to these alternatives. These alternatives will expire on September 24, 2023, regardless of when a device has been added to the alternative.