FDA rules for unique device identification (UDI) of medical devices are finalized

Just as there has been a years-long effort to get a serialization and identification process in place for pharmaceutical packages, there has been a comparable effort for medical devices to have unique device identifiers (UDIs). On Sept. 19, the FDA final rule, encompassing comments and changes from the proposed final rule issued in November 2012, was unveiled. The official record will be published next week in the Federal Register, but a draft version is available now.

“Medical devices” encompass a wide range of goods, from surgical products like bone or tissue implants, to reusable medical tools, to diagnostics equipment and software. Part of the UDI definition process has been how to characterize what types of devices there are, and when devices should have labels on their packaging versus on the device itself. UDIs will contain a “device identifier” (what the product is) and a “production identifier” (lot, serial number and/or date of production). UDIs will be issued by as-yet-unnamed accreditation agencies to be accredited by FDA, and FDA will maintain a Global UDI Database (GUDID) that provides public access to UDIs.

Of particular note to biopharma manufacturers are the rules around combination products that contain a drug. When the drug has its own properly labeled National Drug Code (NDC), a UDI is not required; however, there are conditions where the NDC will be in place for the drug and a UDI for the device component.

Class III devices—those that are implantable or present significant inherent health risk (e.g., heart valves) will require UDIs in September 2014. (A preliminary rule to include a UDI on implantable devices themselves has been dropped.) Class II devices (e.g., infusion pumps) will require them by 2016, and Class I (gloves, healthcare consumables) by 2018.

FDA has mandated goals in establishing the UDI system, including setting up a National Medical Device Postmarket Surveillance System (announced last year) to track and analyze adverse events and health outcomes. FDA also notes that UDIs will streamline distribution practices in private industry, and will be linked up with electronic health record (EHR) systems. While these will present savings to healthcare generally, there will also be a cost, borne primarily by manufacturers, in implementing the UDI system.

Industry support has generally been positive along the way, and continues now. The Advanced Medical Technology Assn. (AdvaMed) issued a statement commending FDA for addressing industry concerns, saying that “this rule is a good step forward.”