The U.S. Food and Drug Administration (FDA) has issued a new guidance to provide answers to frequently asked questions about regulatory and policy issues related to medical device development for devices regulated by the Center for Devices and Radiological Health (CDRH) as well as devices regulated by the Center for Biologics Evaluation and Research (CBER) during the COVID-19 public health emergency.
Among other topics, the guidance provides information about:
- Meetings with industry.
- Medical Device User Fee Amendments (MDUFA) goals and timelines.
- The agency’s policy for marketing submissions or applications currently on hold.
The guidance document is applicable for the duration of the COVID-19 public health emergency. Regulated industry should continue to monitor the FDA’s website and public statements for additional guidance and direction.
Edited by Michael Causey