FDA Pushes Back UDI Submission Compliance Date for Combination Products

The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply.

The compliance date, which the agency extended to Sept. 24, 2019, applies to manufacturers of co-packaged and cross-labeled combination products that are subject to CDER premarket review.

The agency said it is pushing back the deadline because it is “deploying enhancements to GUDID to better accommodate data submissions of combination products that are reviewed by CDER and contain device constituents.”