FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: 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

WASHINGTON, Nov. 10 -- Food and Drug Administration has issued a notice called: 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.

The notice was published in the Federal Register on Nov. 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 Emergency." The guidance describes general recommendations for the validation of in vitro diagnostic devic...