- For Immediate Release:
The U.S. Food and Drug Administration (FDA) continued to take motion within the ongoing response to the COVID-19 pandemic:
- Today, the FDA re-issued the Emergency Use Authorization (EUA) for sure filtering facepiece respirators which might be manufactured in China and should not accepted 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 under these respirators listed within the EUA’s Appendix A as of the date of this re-issuance. Effective instantly, this EUA not contains the three eligibility standards that had been included within the earlier June 6, 2020 authorization letter, that means the FDA will not be reviewing requests and including new respirator fashions to Appendix A based mostly on these standards.
- Testing updates:
- As of at this time, 281 exams are licensed by FDA below EUAs; these embody 219 molecular exams, 56 antibody exams, and 6 antigen exams.
The FDA, an company inside the U.S. Department of Health and Human Services, protects the general public health by assuring the security, effectiveness, and safety of human and veterinary medicine, vaccines and different organic merchandise for human use, and medical units. The company is also accountable for the security and safety of our nation’s food provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.