Silver Spring, MD – The U.S. Food and Drug Administration is taking action in the ongoing response to the COVID-19 Coronavirus pandemic:
The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents.
This page answers questions about adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of COVID-19-related guidance documents and points out a number of adverse event reporting-related resources.
The FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc.’s, DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person’s and population’s exposure to COVID-19 Coronavirus.
The FDA took a meaningful step forward in getting more tests to more Americans more quickly and making that process even easier for developers. This was achieved by posting template updates regarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19 Coronavirus.
Testing updates:
To date, the FDA has authorized 140 tests under EUAs, which include 118 molecular tests, 21 antibody tests, and 1 antigen test.
Additional Resources:
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)
Consumer Inquiries: 888.INFO.FDA
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
