MDUFA Review Delays May Occur During Pandemic, CDRH Cautions

Two senior officials with the Center for Devices and Radiologic Health (CDRH) warned that the center may not meet its Medical Device User Fee Act (MDUFA) review goals during the pandemic.

The heavy pandemic-related workload “means that we are also prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas,” said CDRH Director Jeff Shuren and the director of CDRH’s Office of Product Evaluation and Quality, William Maisel.

CDRH authorized a record number of novel devices in 2020, and it issued 10-fold more Emergency Use Authorizations during COVID-19 “than all other previous public health emergencies combined,” they said in an online update.