Thursday, July 29, 2021

FDA Extends Two UDI Alternatives: UDI-A160001 and UDI-A160002

The two UDI alternatives expire on September 24, 2023.

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FDA - Center for Devices and Radiological Health

FDA Extends Alternatives UDI-A160001 and UDI-A160002

The U.S. Food and Drug Administration (FDA) has extended the following unique device identifier (UDI) alternatives :  

  • UDI-A160001
  • UDI-A160002

This extension means certain nonprescription, over-the-counter devices intended to be sold exclusively through retail establishments may continue to bear a Universal Product Code (UPC) as their device identifier.

These two alternatives expire on September 24, 2023. For more information on the alternatives and a list of the FDA product codes to which the alternatives apply, click Learn More to go to the FDA Decisions section of the UDI Exceptions, Alternatives, and Time Extensions page on FDA.gov.

Learn More

Questions?

If you have questions, contact the FDA UDI Help Desk at GUDIDSupport@fda.hhs.gov.


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