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 NovaSterilis, Inc. for the Nova2200 using the NovaClean decontamination process. FDA revoked the Authorization on February 12, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.