FDA has made other important changes to this provision and the way FDA will implement the provision. Later in this document, we explain that FDA may, on its own initiative or upon the written request of the labeler of a class III device or a device licensed under the PHS Act, grant a 1-year extension of the compliance date applicable to SEC 801.20 when FDA determines that the extension would be in the best interest of the public health. Section 801.35(c) has been revised to require all requests for an exception or alternative to be submitted via email, and we have provided email addresses for requests concerning products regulated by the Center for Biologics Evaluation and Research (CBER), and for all other products. Section 801.35(d) now makes clear that any labeler may make use of an exception or alternative granted under this section, provided that such use satisfies all safeguards or conditions that are part of the exception or alternative. Section 801.35(e) explains that FDA may initiate and grant an exception or alternative if we determine that the exception or alternative is in the best interest of the public health, and explains that any such exception or alternative will remain in effect only so long as there remains a public health need for the exception or alternative. Section 801.55(e) provides that the Center Director may also rescind an exception or alternative granted under this section if, after providing an opportunity for an informal hearing, the Center Director determines that the exception or alternative no longer satisfies the required criteria or that any safeguard or condition required concerning the device has not been met.
CC. Discontinuation of Legacy Identification Numbers Assigned to Devices (National Drug Code and National Health-Related Item Code Numbers)-- SEC 801.57
FDA received several comments (approximately 12).
Three comments recommended a transition period for depletion of devices with legacy identifier that exist in the current supply chain.
FDA believes these comments are adequately addressed by SEC 801.30(a)(1) of the final rule, which provides a limited exception period for existing inventories of finished devices; this is discussed earlier in this document.
Three comments urged FDA not to re-issue any NDC or NHRIC numbers that were previously assigned, because use of a reassigned code could result in confusion in patient records.
Five comments urged FDA to permit labelers to continue using FDA labeler codes that have been assigned to them. These comments explained that many device manufacturers use the FDA labeler code as their GS1 Company Prefix, "the basis for all GS1 product identification numbers." (GS1 operates an existing, widely used system to identify medical devices and other products, and has expressed interest in applying to become an FDA-accrediting issuing agency.) These comments went on to explain that if labelers are forced to discontinue use of the FDA labeler code, they would have to assign new product identifiers to their devices, create new labels and labeling, and that "unnecessary cost and confusion" would result.
FDA agrees with these comments, and we have amended SEC 801.57 to include a new provision, paragraph (c), that will permit a labeler who has been assigned a legacy FDA labeler code to continue to use that labeler code under a system for the issuance of UDIs, provided that such use is consistent with the framework of the issuing agency that operates that system, and that the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code.