Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
May 6, 2024
April 29, 2024
966637d7-cac0-46c1-9ebb-bf25c55c8774
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