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Notice 23 Sep 2025 emergency response, health, in vitro diagnostics, regulatory guidance, fda

⚕️FDA Guidance on In Vitro Diagnostic Tests During Emergencies

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency." This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers' offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.

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Regulatory Compliance, Industry Guidance 7 Jan 2025 fda, public health, healthcare compliance, medical devices, in vitro diagnostics, emergency use authorization

⚕️FDA Announces Draft Guidance for In Vitro Diagnostic Devices

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency. This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy. This draft guidance is not final nor is it for implementation at this time.

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