FDA to require IDs for high-risk medical devices

The U.S. Food and Drug Administration (FDA) has issued regulations that will require most medical devices distributed in the U.S. to display a unique identifying number that will aid in the identification and recall of potentially hazardous devices.


The Final Rule, which was published in the U.S. Federal Register in September 2013, will mandate the use of unique device identifiers (UDIs) by medical device manufacturers. Each UDI will consist of a device identifier that indicates a specific model or version of a device, and a production identifier, which provides a device-specific identification code as well as production information and device expiration date.


Under the new regulations, the FDA will also create a Global Unique Device Identification Database (GUDID) that will allow manufacturers to post UDI information for public access so that consumers can search for up-to-date information on the safety status of a given medical device. The FDA has published a GUDID draft guidance document to aid manufacturers in submitting product information for posting.


The UDI requirements will come into effect over the next seven years, with initial regulations applicable to Class III medical devices effective as of September 24, 2014. The FDA says that the new UDI requirements will allow more timely and accurate reporting and analysis of adverse events associated with specific medical devices, so that unsafe devices can be identified more quickly.


Read the complete text of the FDA’s Final Rule on UDIs (unique device identifiers) for high-risk medical devices.


Read the FDA’s GUDID (Global Unique Device Identification Database) draft guidance document.