There were 24 comments specifically requesting FDA to extend the 1-year compliance date for Class III devices, mostly to 2 years and mostly because the 1-year timeframe is inadequate to locate, rework, and validate new labeling for disparate inventories of existing devices. Separately three comments warned of possible withdrawal or export of non-complying inventory devices and resulting domestic product shortages if UDI requirements were imposed on inventory devices. We have addressed the latter concern by excepting inventory devices for an additional 3 years, during which time these devices can remain on the market without having to comply with UDI requirements. See revised SEC 801.30(a)(1) of the final rule; section II.G (Exception for Existing Inventories of Finished Devices That Have Been Labeled Prior to the Applicable Compliance Date) of this document. Although FDA is not aware of anything to substantiate, specifically, that the 1-year implementation timeframe for class III devices could lead to shortages, FDA has included a new process in the final rule through which FDA may, on our own initiative or upon the written request of the labeler of a class III device or a device licensed under the Public Health Service Act, grant a 1-year extension of the compliance dates for UDI labeling and GUDID reporting when FDA determines that the extension would be in the best interest of the public health. For example, if the sole labeler of a particular class III device provides information showing that it will not be able to comply with UDI labeling requirements within the 1-year timeframe, and showing that a medical device shortage will result if it is unable to continue to ship the device until such time as it can comply with UDI labeling requirements, FDA would consider an extension of the 1-year compliance date. The process for requesting this extension is explained in SEC 801.55(b) of the final rule. FDA believes the availability of this limited exception will allow appropriate flexibility in implementing the final rule, while making it clear that FDA expects most class III devices will remain subject to the 1-year compliance date established by FDA in this document.
Several comments requested clarification concerning whether or when the rule would apply to devices manufactured and labeled prior to the applicable compliance date, or suggested that the final rule should provide an exception for such devices; for example, one comment suggested the rule should provide "an exception for all medical devices which have been manufactured prior to the issue of the final rule."
FDA agrees that it is important to take into account these concerns, and we have done so by providing a limited exception in SEC 801.30(a)(1) of the final rule. We discuss comments on this topic and provide a full response in section II. G., "General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier--Exception for Existing Inventories of Finished Devices That Have Been Labeled Prior to the Applicable Compliance Date--Final SEC 801.30(a)(1)."
Comments suggested that the proposed rule was not clear when the conforming amendments to parts other than 801 and 830 take effect. Under the amended proposed rule, and this final rule, any provision that does not have a more specific effective date would go into effect 90 days after publication of a final rule. One comment also suggested that there is not an immediate need to implement the amendments to part 820, Quality System Regulation, and part 822, Postmarket Surveillance, as "there will be few UDIs to track," and that changes to computer systems will need validation.