09/09/2022: Lab Advisory: HHS Declaration of Public Health Emergency for Mpox Diagnostics and New FDA Guidance

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CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratories

Level: Laboratory Advisory

On September 7, 2022, the U.S. Department of Health and Human Services (HHS) declared that current circumstances justify the authorization of emergency use of in vitro diagnostics to detect and/or diagnose infection with mpox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus. 

In response, FDA issued a guidance document titled Policy for mpox Tests to Address the Public Health EmergencyPolicy for mpox Tests to Address the Public Health EmergencyPolicy for mpox Tests to Address the Public Health Emergency. This document provides:

  • FDA’s review priorities for emergency use authorization (EUA) requests for mpox diagnostic tests
  • FDA’s enforcement policies for certain diagnostic tests that are developed by and performed in a single-site laboratory that are CLIA certified to perform high-complexity testing
  • Recommendations for diagnostic test validation
  • FDA’s enforcement policies for FDA-cleared or authorized mpox diagnostic tests that are modified by a laboratory
  • FDA’s enforcement policies for certain serology tests
  • Templates for laboratories and commercial test manufacturers

Refer to the HHS declaration and the FDA guidance document for more information.

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Centers for Disease Control and Prevention (CDC)

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