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…