FDA Finalized Emergency Diagnostic Test Validation Guidance on November 10, 2026: Typically 30 Positive and 30 Negative Specimens for Emergency Use Tests for Emerging Pathogens
Washington, D.C. — The U.S. Food and Drug Administration finalized guidance on November 10, 2026, on how manufacturers should validate in vitro diagnostic tests for emerging pathogens when the Secretary of Health and Human Services has declared that circumstances justify emergency use authorizations under section 564 of the Federal Food, Drug, and Cosmetic Act. The document followed a draft released January 7, 2025, and comments may be submitted at any time under docket number FDA-2024-D-2707.
The FDA states that the recommendations apply to test data submitted in a pre-EUA or an EUA request, or to tests offered under an applicable enforcement discretion policy. The guidance covers molecular and antigen tests intended to detect a pathogen, designed for use in CLIA certified laboratories, at point of care sites, or at home. Serology and antibody tests are outside its scope. As with all FDA guidance, the recommendations are nonbinding.
On clinical performance, the FDA states that for a viral nucleic acid test built on established, highly sensitive technology, at a stage of an outbreak when samples and comparators are available, at least 30 positive and 30 negative specimens from the intended use population are typically adequate. The agency cites an EUA request for a COVID-19 molecular test validated with only 12 positive samples that showed perfect performance. After 12 more samples were evaluated, cumulative positive percent agreement fell to 71 percent, and the request was withdrawn.
For home use tests, the guidance states that instructions should be limited to one to two pages at no higher than a seventh grade reading level, using only noninvasive collection methods that require no specialized training. The FDA states that the document responds to two independent assessments of its COVID-19 response and is meant to help manufacturers prepare for future outbreaks.
来源链接： https://clpmag.com/lab-management/compliance/fda-finalizes-emergency-diagnostic-test-validation-guidance/
Published by GSM · USA (original Chinese edition)
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