FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China | FDA

FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China | FDA

FDA Reissues EUA for Certain Non-NIOSH Approved Filtering Facepiece Respirators Manufactured in China

Today, the U.S. Food and Drug Administration (FDA) reissued 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 reissued the EUA to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this reissuance. 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.

Read More

Respirators for Health Care Use

The FDA has also provided resources for health care facilities, manufacturers, and distributors, including these flowcharts, to further facilitate the development and availability of these devices for healthcare personnel use in a health care setting:

• Considerations for Selecting Respirators for Your Health Care Facility
• Manufacturing and Distributing Respirators for Health Care Use in the United States During the COVID-19 Pandemic

Questions?

If you have questions about Emergency Use Authorizations related to respirators, contact the Division of Industry and Consumer Education.