The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has changed some of its day-to-day operational procedures and extended some marketing deadlines in response to coping with the COVID-19 medical emergency.
Specifically, CDRH has converted in-person meetings with industry to teleconferences. Where possible, CDRH is leveraging technology to host teleconferences rather than in-person meetings with industry scheduled through April 30, 2020.
CDRH will continue to assess whether any in-person meetings scheduled later than April 30, 2020 should be converted to teleconferences and will provide periodic updates.
CDRH’s Document Control Center continues to receive and process incoming documents. In order to ensure the security of your information, CDRH is generally unable to accept incoming submissions via e-mail. In addition, existing systems have file size limitations associated with e-mail. “We are looking into electronic options other than e-mail,” CDRH says.
CDRH also announced an extension of response due dates for marketing applications on hold as of March 16, 2020. Where the response due date is on or before April 30, 2020, CDRH has extended response due dates by 60 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements), and De Novo classification requests. CDRH intends to extend this due date automatically; no extension requests are necessary to be submitted.
For additional submission types where a response or report is due (e.g., Post Approval or 522 Study reports, Investigational Device Exemption annual reports, PMA reports), CDRH encourages submitting the response or report when possible.
Author: Michael Causey