Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Battelle Memorial Institute for the Battelle Critical Care Decontamination System. FDA revoked the Authorization on April 30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by Battelle Memorial Institute on April 2, 2021. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.