The U.S. Food and Drug Administration released a FAQ on testing for monkeypox virus. This section is primarily intended for monkeypox test developers.
This section provides answers to frequently asked questions relating to the development and performance of tests for monkeypox. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.
This section includes questions and answers regarding the policies described in the FDA's Policy for Monkeypox Tests to Address the Public Health Emergency.
Tests being offered prior to or without an EUA as described in the FDA's Policy for Monkeypox Tests to Address the Public Health Emergency have not been reviewed or authorized by the FDA. As stated in the FDA's Policy for Monkeypox Tests to Address the Public Health Emergency, all such tests should be validated by the developer prior to being offered for clinical use.
Note: Throughout this section and the FDA's Policy for Monkeypox Tests to Address the Public Health Emergency, references to laboratories that are "certified to perform high complexity testing under CLIA" or to "high-complexity CLIA-certified laboratories" are referring to single site laboratories that are certified under CLIA that meet the requirements to perform tests of high complexity.
