Health Law Daily Wrap Up, MEDICAL DEVICES—NOTICES: FDA announces Mpox diagnostic test EUA, (Aug 7, 2026)

By WK Editorial Staff

FDA published the authorization notice as part of its ongoing emergency response framework for mpox, making the terms and rationale for the diagnostic test's use publicly available.

The Food and Drug Administration announced the issuance of an Emergency Use Authorization (EUA) for the Allplex HSV-1&2/VZV/MPXV Assay, an in vitro diagnostic test developed by Seegene USA, Inc., for the simultaneous detection and differentiation of monkeypox virus (MPXV), herpes simplex virus types 1 and 2, and varicella-zoster virus. The authorization was issued on July 9, 2026, under the FDA’s emergency use authority stemming from the ongoing public health emergency declaration related to mpox. FDA determined that the statutory criteria for emergency authorization were met, including that the test may be effective and that no adequate, approved, and available alternative exists for the authorized use. The EUA permits use of the test by authorized laboratories and is subject to numerous conditions governing labeling, distribution, performance monitoring, adverse event reporting, and ongoing evaluation of the assay’s effectiveness (Notice, 91 Fed. Reg. 50848 (Aug. 6, 2026).

Dates. The Authorization is effective as of July 9, 2026.

FederalRegisterIssuances: Notices FDCActNews MDeviceNews