- 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 reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test, which is now authorized for use with pooled samples containing up to four individual upper-respiratory swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
- In a new FDA Voices, titled FDA Protects Patients and Consumers from Fraud During COVID-19, agency leaders explain that the FDA’s consumer protection work is a cornerstone of the agency’s mission and a critical component of its pandemic response efforts.
- In another new FDA Voices, titled FDA’s Continued Commitment to the Safety and Security of Our Laboratories, agency leaders explain that laboratory safety is of the highest priority in all of the agency’s scientific research and analytical facilities.
- Today, FDA announced that it is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps). As a result of the challenges presented by the COIVD-19 public health emergency, the agency is extending the enforcement discretion policy for an additional six months (through May 2021).
- Today, the FDA immediately implemented and issued a guidance intended to help expand the availability of transport media used to transport certain clinical specimens for testing during the COVID-19 public health emergency. The FDA also posted answers to frequently asked questions relating to the development and use of transport media during the COVID-19 public health emergency.
- Testing updates:
- To date, the FDA has currently authorized 186 tests under EUAs; these include 153 molecular tests, 31 antibody tests, and 2 antigen tests.
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