2023-08641: Authorization of Emergency Use of a Medical Device During COVID-19; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for a medical device related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorization indicated in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is specified in this document, and can be accessed on FDA's website from the links indicated.

The agency’s own summary, as published.