Medical Device Companies Preparing for New FDA Regulations

On September 20, 2013, the FDA announced a final rule for the Unique Device Identification (UDI) system.

A UDI is a unique identifier for each medical device sold in the United States. The UDI along with information on the device’s components must be registered in a global database, known as the Global Unique Device Identification Database (GUDID).

The ruling means that labels and packages of class III medical devices, such as pacemakers and heart valves, conform to new UDI rules by September 24, 2014. Deadlines for class II and I devices occur progressively over the next seven years.

The FDA believes the UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help identify product problems more quickly, better target recalls and improve patient safety.

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a press release recently issued by the FDA.

USDM is helping some of the world’s most well recognized medical device companies prepare for the new UDI regulations.