Policy for monkeypox tests to address the public health emergency

Sept. 12, 2022
Guidance for laboratories, commercial manufacturers, and Food and Drug Administration staff.

The U.S. Food and Drug Administration released guidance to address the monkeypox outbreak.

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.

In light of the public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being issued without prior public comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

FDA release