Under 21 CFR 801.55(c), FDA is granting with conditions, for the devices identified below, an extension of the alternative UDI-A160001 to the requirements of 21 CFR 801.20, regarding Unique Device Identifier (UDI) label and device package requirements.
This alternative applies specifically to the (PRODUCT DESCRIPTORS [REDACTED]) intended to be sold exclusively at retail, listed in the table below by their device classification product codes and corresponding regulations (hereafter referred to as “[REDACTED]”). (FDA Note: The devices to which this alternative applies are specified by the FDA Product Code and regulation number.)
The alternative expires on September 24, 2023.
|FDA Product Code||FDA Product Code Name||Regulation (21 CFR)|
FDA is extending alternative UDI-A160001, under which these [REDACTED] may continue to bear a Universal Product Code (UPC) as their device identifier. FDA has determined that alternative use of the UPC would, for the time being, provide for more rapid identification of these devices while labelers establish or finalize the internal processes and procedures needed to comply with UDI requirements and also when accounting for the present state of technology at retail.
Based on information provided in extension requests, FDA understands that many retail establishments currently may be better prepared to rapidly identify a device through a UPC than a UDI given the inability of certain retail technology to read and interpret UDIs in automatic identification and data capture (AIDC) form. 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 these devices at this present time may facilitate recalls and other corrective actions that might be required concerning these retail devices.
Further, FDA recognizes the ongoing resource strains that the COVID-19 public health emergency (PHE) has imposed on the medical device industry and acknowledges that the PHE may have affected the ability of some labelers to establish or finalize comprehensive processes and procedures for compliance with UDI requirements. Therefore, FDA considers a two-year extension of alternative UDI-A160001 through September 24, 2023, appropriate.
The alternative extension is granted with the following continuing 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 Code [REDACTED], regulated under 21 CFR [REDACTED] intended to be sold exclusively through retail establishments.
- This alternative does not apply to these devices if they are intended to be sold exclusively by prescription or sold to, distributed to, or used in health care settings.
- The UPC must be submitted to the Global UDI Database (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-A160001. 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 at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm.
- 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.