Combo Products: FDA Delays Compliance Date for UDI Submissions

Regulatory NewsRegulatory News | 09 August 2018 |  By 

Manufacturers of combination products reviewed at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) received a year-long extension on Thursday to comply with certain unique device identification (UDI) requirements.
The extension on the compliance date for the device components of co-packaged and cross-labeled combination products relates to the requirements on data submissions to FDA’s Global UDI Database (GUDID) under the 2013 UDI regulation.

“We are deploying enhancements to GUDID to better accommodate data submissions of combination products that are reviewed by CDER and contain device constituents,” Steven Luxenberg, associate director for health informatics at FDA’s Center for Device and Radiological Health (CDRH), wrote in the Thursday letter to the affected manufacturers. “Similar enhancements are not required for combination products reviewed by CBER [Center for Biologics Evaluation and Research],” Luxenberg added.

Pending the GUDID system updates, the compliance date for GUDID submissions was extended from 24 September 2018 to 24 September 2019.

"The enhancements to GUDID are primarily focused on the FDA premarket submission fields in GUDID, and will enable those combination product labelers targeted in the enter complete information in GUDID," CDRH spokesperson Deborah Kotz told Focus. "If a combination products labeler who is subject to UDI requirements has already complied with GUDID submission requirements, there is no need to take additional action in response to this extension."

The road to implementing a national UDI system has presented some unique challenges. The new notice follows a string of similar extensions on other UDI requirements for different device types.

It is also the second of its kind. The first extended the initial deadline of 6 September 2016 for requirements on both GUDID submissions and UDI labels for combination products assigned to CDER or CBER, though the UDI labeling compliance for these products remains unchanged.

Previously implemented extensions on UDI requirements date back to at least 2015, following a security flaw detected in GUDID that resulted in an additional month for manufacturers of some device types to comply. Last year, CDRH also granted a third extension for soft contact lens.

Meanwhile, GUDID has been undergoing a transformation that extends beyond the updates planned for combination products. Other changes relate to the push for global harmonization of device codes and terminology via the International Medical Device Regulators Forum.

Updated on 8/13/18 with comments from CDRH.


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