Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens 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
November 10, 2026
November 9, 2026
09c36b30-818f-4b05-8c6b-971e6b5a0a0a
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