Sep 12, 2022

New guidance from the US Food and Drug Administration establishes emergency market access for in vitro diagnostic (IVD) tests to diagnose monkeypox infections. The US Department of Health and Human Services, which oversees the FDA, determined in early September 2022 that the monkeypox outbreak poses a significant enough public health challenge that emergency use authorizations (EUAs) are warranted.

According to the FDA guidance as well as an accompanying FAQ document, the agency intends to prioritize reviews of emergency use authorization (EUA) applications for the following test types:

  • High-throughput diagnostic tests
  • Tests with home specimen collection
  • Rapid diagnostic tests

Manufacturers seeking EUA designations for monkeypox diagnostic tests should first email FDA regarding their submission plans before sending their full EUA requests to the agency.

FDA policy also seeks to expand monkeypox testing capabilities at healthcare facilities, reference laboratories and commercial laboratories, according to the agency guidance.

Additional components of the new guidance include:

  • Procedures to support monkeypox test development at laboratories certified to perform high-complexity testing according to the Clinical Laboratory Improvement Amendments (CLIA)
  • Recommendations for manufacturers regarding modification of previously cleared or EUA-designated molecular diagnostic tests for monkeypox
  • Guidelines for notification procedures, reporting of test results and coordination with FDA

Emergo by UL consultants will provide any updates regarding FDA’s EUA policies for monkeypox diagnostic tests as the agency makes them available.

Learn more about US FDA EUA and related medical device regulatory processes:

Author

  • Stewart Eisenhart

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