Policy for Monkeypox Tests To Address the Public Health Emergency; Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Policy for Monkeypox Tests To Address the Public Health Emergency." On August 4, 2022, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency related to monkeypox. Monkeypox virus is a zoonotic infection (a virus transmitted to humans from animals), caused by Orthopoxvirus genus of the Poxviridae family similar to variola virus (the causative agent of smallpox), and can spread to humans. Since early May 2022, cases of monkeypox have been reported from countries where the disease is not endemic and continue to be reported in several endemic countries. Rapid detection of monkeypox cases in the United States requires wide availability of diagnostic testing to control the emergence of this contagious infection. This guidance describes FDA's review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, as well as FDA's enforcement policies for various monkeypox tests. The guidance document has been implemented without prior comment, but it remains subject to comment in accordance wit