UPC Allowed for Some Devices

FDA-CDRH has recognized that retail establishments are better prepared to identify a device through a UPC than a UDI, because the technology is not prepared to read a UDI in AIDC form. As a result, there is an alternate for some devices until September 24, 2021; FDA anticipates that by that date, retail establishments will have UDI-compatible technology in place.

The alternative has the following conditions:

  • A specified list of product codes
  • Not intended to be sold exclusively by prescription
  • Not sold to, distributed to, or used in health care settings
  • The UPC is the primary device identifier (DI) in GUDID
  • The alternative is documented in the DMR, 820.181(d), and copy of the alternative is also in the DMR

The alternate is available on the FDA website at UCM517297, which links to the list of product codes.