UDI Database Deadline Extended Again For Certain Combo Products

10 Aug 2018

Following an extension for Unique Device Identifier requirements for low-risk devices earlier this summer, US FDA has pushed back a deadline to input UDI date into its GUDID database for combination products that go through the drug center. Manufacturers, however, are still required to implement UDIs labeling by Sept. 24.

Makers of certain drug-device or biologic-device combination products have an extra year to comply with US FDA's requirement to submit Unique Device Identifier (UDI) data into its Global Unique Device Identification Database (GUDID). The agency says it needs the extra time to update the GUDID system but also notes such products will still need to adopt UDI on product labeling by Sept. 24, 2018.

Makers of the co-packaged combination products that are assigned to the Center for Drug Evaluation and Research (CDER) as a...