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# FDA Emergency Monkeypox Test Guidance
- URL: https://www.fdaweb.com/fda-emergency-monkeypox-test-guidance/
- Published: 2022-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:58:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152696

FDA has published an immediately effective guidance, *Policy for Monkeypox Tests to Address the Public Health Emergency*, describing the agency’s review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-monkeypox-tests-address-public-health-emergency?ref=fdaweb.com) also covers the FDA enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments 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 the agency’s enforcement policies for certain serology tests.

A separate FDA [notice](https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-takes-significant-action-help-expand-access-testing?ref=fdaweb.com) says the agency also is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request.

The guidance follows a declaration by HHS justifying the emergency use of *in vitro* diagnostics for the detection and/or diagnosis of the monkeypox virus. Under the declaration, FDA may issue an EUA to allow the use of unapproved *in vitro* diagnostics or unapproved uses of approved *in vitro* diagnostics, the notice says.