The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
- As part of FDA’s effort to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19 products. The company, Curativa Bay Corporation, offers Hypochlorous Skin Spray, a topical hypochlorous acid-containing product for sale in the United States with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
FDA updated the templates for laboratories and commercial manufacturers to help facilitate submission of Emergency Use Authorization (EUA) requests for serology tests. The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data; the updates also provide new recommendations for validation of point-of-care tests.
- Testing updates:
- To date, there are 153 currently authorized tests under EUAs; these include 129 molecular tests, 23 antibody tests, and 1 antigen test.