Version 1.1: April 29, 2019

FDA is granting, with conditions, an alternative for [REDACTED] to the requirements of 21 CFR 801.20, regarding both unique device identifier (UDI) label and device package requirements, for sterile class III devices; sterile implantable, life-supporting, or life-sustaining (I/LS/LS) devices; and sterile class II devices that were manufactured and labeled prior to their UDI compliance date and are still held in inventory after the 3-year expiration of the exception provided under 21 CFR 801.30(a)(1) (“these sterile devices”). Specifically, FDA has determined that this alternative, under which the UDIs for these sterile devices could be derived from existing information on the label, would better ensure the safety or effectiveness of the devices. Our conclusion is based on the fact that, unlike the processes required to relabel these sterile devices with UDI-compliant labeling, the alternative will not risk compromise of device sterility or device performance.

This alternative for existing inventory expires ten years after the compliance date, or when these sterile devices have reached the end of their shelf life (whichever comes sooner), as specified in the following table. Date format requirements under 21 CFR 801.18 and direct mark requirements under 21 CFR 801.45, if applicable, are extended until the expiration of this alternative.

This alternative is granted with the following conditions, which are appropriate to ensure the adequate identification of these devices through distribution and use:

1. This alternative applies only to labelers of class III, I/LS/LS, and class II sterile devices manufactured and labeled before their applicable UDI compliance date and with a shelf life of longer than three years.
2. Device identifiers (DIs) must be assigned to these sterile devices and corresponding DI records must be submitted to the Global Unique Identification Database (GUDID) prior to the expiration of the applicable 3-year inventory provision under 21 CFR 801.30(a)(1). These DI records must include the device catalog number in the “Catalog Number” field of the DI record to allow the DI to be derived from the catalog number.
3. Labelers must develop and make available to device users a method for constructing the UDI from information on the label (such as catalog number and lot or serial number).
4. The alternative number for this alternative is UDI-A170001. FDA is planning to make database enhancements to capture basic alternative information, such as the alternative number, in the GUDID. 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) is(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 the Global UDI Database (GUDID) home page.
5. 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, as well as a description of the method for constructing the UDI from information on the label and the means by which this method is being made available to device users, should also be included in the DMR.

Decision for FDA UDI Alternative UDI-A170001 - Document History

Version	Date	Change
1.0	April 6, 2017	Original
1.1	April 29, 2019	Extended expiration date by five years