The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has met the COVID-19 pandemic head-on with aggressive “regulatory flexibility,” the center says in what amounts to a report card it has issued on its performance since the beginning of 2020.
“If you want to know the FDA’s impact on COVID-19, look no further than the numbers,” says Stephen M. Hahn, MD, Commissioner of Food and Drugs. CDRH’s “response to the pandemic has been unprecedented in terms of volume, speed, and agility—spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment, and extensive engagement with stakeholders,” Hahn says.
Specifically, the center issued 23 guidance documents and authorized 516 medical products under EUAs, which is almost 10 times the number authorized in all prior national emergencies, CDRH says. Of the medical products, 248 were tests in the following categories:
- 198 molecular tests
- 4 antigen tests
- 46 antibody tests
Overall, the FDA received 1,734 pre-EUAs and 3,040 EUAs between January 1 and September 18, 2020. In that same time frame, CDRH deployed 58 Commissioned Corps officers a total of 78 times in support of the COVID-19 mission.
CDRH also sent 13.7 million e-mails to stakeholders on COVID-19 topics; responded to 337,000 e-mail and phone queries from patients, healthcare personnel, industry, and others; and hosted 39 COVID-related webinars and town halls with more than 36,000 participants.
Edited by Michael Causey
