FDA (CDRH)
GUIDANCE FINAL
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
Published: 11/10/2026Detected: 11/9/2026
Summary preview
Clarifies FDA’s expectations for validating certain in vitro diagnostic (IVD) devices intended for emerging pathogens when the device is developed or used under a Section 564 declared emergency.
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manufacturing
quality
clinical
safety
labeling
#Section 564 declared emergency
#IVD
#emerging pathogens
#validation
#analytical performance
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