Lynn Shapiro Snyder, a Senior Member of the Firm in the Health Care and Life Sciences and Litigation practices, in the firm’s Washington, DC, office, and Lauren A. Farruggia, a Summer Associate, authored an article in the Food and Drug Law Institute (FDLI) Update, titled “The 'New' NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?”
Following is an excerpt (see below to download the full version in PDF format):
On September 24, 2014, The U.S. Food and Drug Administration (FDA) issued its final rule on establishing the framework for an ambitious Unique Device Identification System. The plan, which will take several years to fully implement, seeks to identify most medical devices through distribution and use. Ultimately, the unique device identifier (UDI) system will require most medical device manufacturers to include a UDI on the medical device’s labeling in human- and machine-readable form, and to submit medical device product information to FDA’s Global Unique Device Identification Database (GUDID). FDA hopes that this UDI system will reduce medical errors, simplify the integration of medical device use information into data systems, provide faster identification of individual medical devices with adverse events, create faster solutions for reported problems, facilitate more rapid recalls, and improve FDA safety communication.
