Manufacturers of combination products reviewed at the United States (US) Food and Drug Administration’s (FDA) Centre for Drug Evaluation and Research (CDER) have a received a year-long extension to comply with certain unique device (UDI) requirements.
The extension on the compliance date for the device components of co-packaged and cross-labelled combination products is related to the requirements on data submissions to the FDA’s Global UDI Database (GUDID) under the 2013 UDI regulation. Due to the pending GUDID system updates, the compliance date for GUDID submissions has been extended from 24th September 2018 to 24th September 2019.
The FDA stated that they are enhancing the GUDID to better accommodate data submissions of combination products that are reviewed by CDER and contain device constituents. Implementing a national UDI system has presented some challenges and the new notice follows similar extensions on other UDI requirements for different device types.
The first notice extended the initial deadline of 6th September 2016 for requirements on both GUDID submissions and UDI labels for combination products assigned to CDER or the Centre for Biologics Evaluation and Research (CBER), although the UDI labelling compliance for these products remains unchanged.
Furthermore, GUDID is in the process of a transformation that extends beyond the updates that are planned for combination products. Further changes are regarding the push for global harmonisation of device codes and terminology via the International Medical Device Regulators Forum.
To view the notice on extending the compliance date for GUDID submission requirements of device constituents of co-packaged combination products assigned to CDER for premarket review, please click here.