FDA has proposed that most medical devices distributed in the U.S carry a Unique Device Identifier (UDI). The UDI would allow for more accurate reporting of adverse events, reduce medical errors by enabling healthcare professionals to precisely identify a device, provide a uniform way to enter information into EHRs, provide for a standardized identifier to enable manufacturers, distributors, and healthcare facilities to better manage medical device recalls, and the UDI would provide the foundation for a global secure distribution chain.
A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device such as the expiration date plus batch or lot number. This information would be available in a publicly available UDI database but no identifying patient information would be stored in the device information center.
The FDA has worked closely with industry, the clinical community, patient and consumer groups, and conducted four pilot studies to work on developing this proposed rule. As a result, a notice on the proposed rule was published in the Federal Register on July 10th and seeks comments on the proposed rule.
The FDA is proposing a risk-based-in approach to implementation, focusing on the highest risk medical devices first and exempting low risk devices from some or all of the requirements. The FDA is proposing to exempt over the counter devices sold at retail since these devices generally have UPC codes in place.