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Zdrowie i gospodarka · 17/04/2023

FDA Authorizes Emergency Use of In Vitro Diagnostic Device for Mpox Detection

The FDA has issued an Emergency Use Authorization (EUA) for an in vitro diagnostic device to detect mpox, following a public health emergency declaration by the Secretary of HHS in September 2022. The authorization was requested by Cue Health, Inc. and is subject to certain conditions.

Source: Federal Register — Food and Drug AdministrationOpen original release →