Policy for Monkeypox Tests to Address the Public Health Emergency

On 13 September 2022 the FDA published final guidance on monkeypox tests for laboratories, commercial manufacturers and FDA staff.

This guidance describes FDA's review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, describes FDA's enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity, provides recommendations for diagnostic test validation, describes FDA's enforcement policies for FDA-cleared or authorized monkeypox diagnostic tests that are modified, and describes FDA's enforcement policies for certain serology tests.