FDA is granting, with conditions, [REDACTED] request for an alternative to the requirements of 21 CFR 801.20, regarding both UDI label and device package requirements, for [REDACTED] devices (FDA product codes [REDACTED], regulated under 21 CFR [REDACTED]) intended to be sold exclusively at retail ("these retail devices"). (FDA Note: The devices to which this alternative applies are specified by the FDA Product Code and regulation number.) Specifically, FDA has determined that this alternative, under which these retail devices will bear a Universal Product Code (UPC), would better ensure the safety of the device with respect to device identification for a time-limited period. Our conclusion is based on the fact that the alternative will provide for more accurate and rapid device identification until the technological capability of retailer systems evolves, because the alternative can be read and interpreted at the retail transaction level immediately.
Retail establishments are currently better prepared to accurately and rapidly identify a device through a UPC than a UDI, given the inability of retail technology to read and interpret UDIs in AIDC form at this time. Retail establishments use the UPC to uniquely identify and track devices in product inventories and commercial transactions. Consequently, the use of a UPC to identify the subject devices may facilitate recalls and other corrective actions that might be required concerning a device at the present time. Because of the risk profile of these retail devices, we believe that more accurate and rapid identification better ensures the safety of these retail devices with respect to identification, even though the identification will be less precise. This alternative expires on September 24, 2021, because FDA anticipates that by that date, retail establishments will have UDI-compatible technology in place. A request to extend this date may be submitted within 1 year of this alternative’s expiration.
The request is granted with the following conditions, which are appropriate to ensure the adequate identification of these devices through distribution and use:
- This alternative applies only to labelers of [REDACTED] (FDA product codes [REDACTED], regulated under 21 CFR [REDACTED]) intended to be sold exclusively through retail establishments. (FDA Note: The devices to which this alternative applies are specified by the FDA Product Code and regulation number.)
- This alternative does not apply to these devices if they are labeled for “Rx only” or “Professional Use Only.”
- The UPC must be submitted to the GUDID as the primary device identifier (DI).
- The package DIs, or the UPCs in the case where a UPC is on the higher levels of packaging, must be entered in the GUDID.
- The alternative number for this decision is UDI-A160002. FDA is planning to make database enhancements to capture basic information about any alternative decision being relied on by a labeler, such as this alternative number, in the GUDID. FDA does not currently have a timeframe for this enhancement, but we will announce this change on the FDA UDI webpage (www.fda.gov/udi) and through CDRH email notification services. After the new field(s) are added to accommodate this information, we expect you to enter this alternative information in the DI records for the devices to which this alternative applies within 45 days of personal notification of the database enhancement from FDA. We encourage you to subscribe to receive notification about GUDID changes and system status.
- The applicability and use of this particular alternative must be documented in the device master record (DMR) as part of the labeling specifications required under 21 CFR 820.181(d) for each respective device. A copy of this alternative decision should also be included in the DMR.