The FDA’s new UDI regulation places a significant burden on medical device firms to mine vast stores of product data for the information required to prepare and electronically file UDI-compliant submissions. Learn how the PTC UDI Solution dramatically reduces the complexity and cost of compliance.
UDI Compliance without Complexity
In order to improve patient safety, the FDA created a new regulation requiring the standard identification of every medical device throughout its supply chain journey. To meet this newly proposed regulation for UDI (Unique Device Identification), medical device manufactures and their suppliers must label every product, product version, and product configuration with a unique, 14-digit identifier. What’s more, a wide range of critical device information is required to be submitted to the FDA’s new GUDID (Global Unique Device Identifier Database) to more effectively track adverse events and safety issues to specific products. Not complying with this regulation would bar device sales across state lines, which means that noncompliance is not an option for medical device manufacturers in the US.
Working with the FDA and major medical device manufacturers, PTC has developed an efficient, cost-effective solution to help companies manage UDI submissions and gain compliance, while ensuring scalability to meet future FDA or worldwide requirements for UDI.