FDA GUIDANCE · FINALSeptember 23, 2025

Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Outbreak, IVDs (In Vitro Diagnostic Devices)

Issue date

September 23, 2025

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