WASHINGTON, Aug. 6 -- Food and Drug Administration has issued a notice called: Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability.
The notice was published in the Federal Register on Aug. 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of Mpox. FDA has issued an Authorization for an in vitro diagnostic device, Allplex HSV-1&2/VZV/MPXV Assay, for the simultaneous qualitative detection and differentiation of ...