Source: US Food and Drug Administration
- For Immediate Release:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- Today, the FDA re-issued the Emergency Use Authorization (EUA) for certain filtering facepiece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH). The FDA re-issued the EUA to authorize emergency use for only those respirators listed in the EUA’s Appendix A as of the date of this re-issuance. Effective immediately, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria.
- Testing updates:
- As of today, 281 tests are authorized by FDA under EUAs; these include 219 molecular tests, 56 antibody tests, and 6 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.