HHS Authorizes FDA to Issue EUAs for Monkeypox Tests, Quest Diagnostics Gets First Authorization

The US Department of Health and Human Services announced on Wednesday that it has authorized the Food and Drug Administration to issue emergency use authorizations for monkeypox tests.

HHS Secretary Xavier Becerra signed a declaration under section 564 of the Federal Food, Drug, and Cosmetic Act to allow the FDA to issue EUAs for in vitro diagnostic tests to detect and/or diagnose monkeypox virus, including tests for non-variola orthopoxvirus.

“Today’s action is an important step forward in our monkeypox response by allowing the FDA to facilitate the development of more validated monkeypox tests and expand access to testing,” Becerra said in a statement.

The decision comes one month after the agency declared a public health emergency for monkeypox.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/hhs-authorizes-fda-issue-euas-monkeypox-tests-quest-diagnostics-gets#.Yxtzr3bMKUk