FDA Begins MDUFA V Talks, Notes Slower Reviews During Pandemic

The FDA is having difficulty in meeting its performance goals under the Medical Device User Fee Amendments (MDUFA) IV program due to the COVID-19 pandemic and expects product review delays to get worse until the crisis is over.

In an Oct. 27 virtual meeting to begin negotiations for the next MDUFA program, MDUFA V, Barbara Zimmerman, deputy director of CDRH’s Office of Regulatory Programs, said the FDA met most of its performance goals in 2018 and 2019 under MDUFA IV, but the COVID-19 pandemic has slowed the agency.

Although Emergency Use Authorizations (EUA) and pre-EUA submissions are not part of the agency’s MDUFA commitments, they have contributed significantly to the agency’s workload in 2020, Zimmerman said. The FDA has received roughly 4,500 pre-EUAs and EUAs, and the total volume of submissions received has doubled compared to a year ago, she said.