CDRH Letter to Manufacturers of Drug/Device or Biologic/Device Combination Products Assigned to CDER for Premarket Review

CDRH Letter to Manufacturers of Drug/Device or Biologic/Device Combination Products 
Assigned to CDER for Premarket Review

On September 6, 2016, the Center for Devices and Radiological Health (CDRH) published a letter in which we clarified that the compliance date for UDI label and GUDID submission requirements is September 24, 2018, for device constituents of 21 CFR 3.2(e)(2) (commonly referred to as “co-packaged”) and 21 CFR 3.2(e)(3) (commonly referred to as “cross-labeled”) combination products assigned to Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER)  for premarket review.

We are deploying enhancements to GUDID to better accommodate data submissions for combination products that are reviewed by CDER and include device constituents. We therefore are extending the compliance date for GUDID submission requirements of device constituents of co-packaged combination products assigned to CDER for premarket review to September 24, 2019.

If you have any questions, please contact the FDA Office of Combination Products at combination@fda.gov or submit your question to the UDI Help Desk.

Thank you,

Food and Drug Administration

Center for Devices and Radiological Health