FDA issued a letter to industry that includes steps the agency's Center for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nation’s response during the Coronavirus (COVID-19) public health emergency.
The agency said these steps seek to address the impact of COVID-19 on day-to-day operations in CDRH and in the medical device industry, while ensuring that government and private sector efforts to respond to the emergency receive the highest priority.
- CDRH has converted in-person meetings with industry to teleconferences for any meetings with industry scheduled through April 30.
- The agency continues to receive and process incoming documents. CDRH is also looking into electronic options other than email for receiving documents, noting that it does not accept submissions by email for security reasons as well as file size limitations.
- For marketing applications on hold as of March 16, where the response due date is on or before April 30, CDRH has extended the response due date by 60 days for premarket approval applications (PMA; original and supplements), 510(k) notifications, humanitarian device exemptions, and de novo classification requests. The agency intends to extend this due date automatically, so no extension requests are necessary. For additional submission types where a response or report is due such as post-approval or 522 study reports, investigational device exemption annual reports, or PMA reports, the industry is encouraged to submit those when possible. Questions about response due dates should be sent to CDRHPremarketProgramOperations@fda.hhs.gov.
- CDRH said it continues to process and work on mission-critical post-market and compliance activities.
How to submit an inquiry or request for an emergency use authorization (EUA)
Companies that have developed in vitro diagnostics (IVDs) for detection and/or diagnosis of the virus that causes COVID-19 or personal respiratory protective devices are "strongly" encouraged to submit pre-EUAs to discuss technologies that might help address this emergency.
- For inquiries related to EUAs for IVDs, contact CDRH-EUA-Templates@fda.hhs.gov
- For inquiries related to EUAs for non-IVDs, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov
- For more information about the EUA program, see the guidance, Emergency Use Authorization of Medical Products and Related Authorities.