- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued a guidance document, titled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers,” with answers to frequently asked questions. These include answers concerning certain aspects of sponsor requests for formal meetings with the FDA, user-fee application goals and timelines, and other regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.
- As part of the FDA’s continuing effort to protect consumers, the agency issued a warning letter to one firm for selling fraudulent COVID-19 products. The seller, North Isle Wellness Center, offers Methylene Blue products for sale in the United States with misleading claims that the products can mitigate, prevent, treat, , or cure COVID-19 in people. The letter requests that the seller take immediate action to cease the sale of such unapproved and unauthorized products. 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.
- Testing updates:
- To date, the FDA has authorized 145 tests under EUAs; these include 122 molecular tests, 22 antibody tests, and 1 antigen test.
The 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.
- Lee Herring