Personal Protective Equipment EUAs | FDA

Personal Protective Equipment EUAs | FDA

Coronavirus (COVID-19) Update: Daily Roundup October 15, 2020

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.

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Additional Resources:

• FAQs on Testing for SARS-CoV-2
• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)