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Business · 10/11/20261 min read

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; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared…

Original source language: Federal Register — Health and Human ServicesOpen original release →

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