Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA re-issued an emergency use authorization (EUA) for the Assure COVID-19 IgG/IgM Rapid Test Device, making it the first authorized serology (antibody) test that can be used at the point of care (POC), meaning it is authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The FDA added one new device to the Device Discontinuance List on the Medical Device Shortages During the COVID-19 Coronavirus Public Health Emergency web page. There are no updates to the Device Shortage List.
Since the web page was first published, the FDA also updated the web page to clarify how we determine what devices are in shortage, as well as how the analysis informs other measures the FDA uses to help address the public health emergency, including issuing Emergency Use Authorizations (EUAs) and providing enforcement discretion for products that play an important role in meeting demand, as well as working with other federal partners.
The FDA will continue to update the lists as the COVID-19 Coronavirus public health emergency evolves.
FDA developed new health education materials that have been culturally and linguistically tailored for diverse consumers. These materials are intended for health care professionals to share with their patients to help stimulate dialogue and answer pressing questions about FDA’s response to COVID-19 Coronavirus.
The materials provide information on the different areas of the FDA’s response to the pandemic, including health fraud, medical product supply, therapeutics, vaccine development, and diagnostic and antibody testing.
As of today, 254 tests are authorized by FDA under EUAs; these include 203 molecular tests, 47 antibody tests, and 4 antigen tests.
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.