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NEW YORK — The US Food and Drug Administration today issued a final guidance to provide updated information about the application process for its Humanitarian Device Exemption (HDE) Program, firming up a draft guidance for this regulatory pathway issued in June 2018.
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.