On the basis of this determination, on September 7, 2022, the Secretary of HHS subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 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 United States citizens living abroad that involves monkeypox virus. Although there is a very low risk of death, there have been reported complications including severe pain, at times requiring hospital admission. usually presents as a rash on the body, face, or genital area. It typically resolves on its own without treatment. Monkeypox (mpox) is a non-variola Orthopoxvirus and is generally not fatal. The variola virus, which causes smallpox and has been eradicated globally, is another type of Orthopoxvirus. Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox (mpox) Tests. FDA Cleared and EUA-Authorized Monkeypox (mpox) Tests.Information for Monkeypox (mpox) Test Developers.
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