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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 23, 2025

September 22, 2025

Center for Devices and Radiological Health

21848893-1a28-4ffe-a5eb-e86a79546ffb

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