Do you have a medical device cleared under Emergency Use Authorization (EUA) during the COVID-19 crisis?
Section 564 of the FD&C Act allows the FDA to issue EUAs to otherwise unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives. During the COVID-19 crisis, FDA has issued more than 200 EUAs for medical devices to combat the pandemic. With all of these EUAs recently released, companies new to the medical device industry might wonder how to comply with adverse event reporting requirements.
Complying with adverse event reporting requirements for EUA devices:
First, look at the Conditions of Authorization! Each EUA contains an individualized Conditions of Authorization, which will detail the adverse event reporting requirements for the device. You can expect the reporting requirements to be similar to the general reporting requirements of 21 CFR Part 803. The FDA guidance document “Questions and Answers about eMDR – Electronic Medical Device Reporting” explains how manufacturers can comply with the FDA requirement to submit electronic reports of individual medical device adverse events.
The timing of adverse event reporting is also important. Manufacturers must submit MDRs no later than 30 days after becoming aware of the reportable event. Or, if the event requires remediation to prevent a risk of substantial harm to the public health, the manufacturer must submit the MDR within 5 days of becoming aware of the event.
Finally, the MDR should include the correct product code for the device. Product codes are accessible in the FDA classification database. Manufacturers with questions about adverse event reporting for EUA medical devices can email this address: COVID19-DeviceReporting@fda.hhs.gov.
Find more answers to your COVID-19 EUA questions at the FDA Q&A page.
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