FDA Writes Pandemic Test Playbook For Next Disease Outbreak
Published Date: 1/7/2025
Notice
Summary
The FDA just dropped a draft guide to help companies quickly test new lab devices that spot emerging germs during health emergencies. This guide shows how to prove these tests work before or during an emergency, making it easier and faster to get them approved. If you make or use these tests, check it out and send your thoughts by March 10, 2025—no extra costs yet, but it could speed things up big time!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Draft IVD Validation Guidance
If you make in vitro diagnostic (IVD) tests for emerging pathogens, the FDA released a draft guidance that explains general recommendations for how to validate those tests during a Section 564 declared public health emergency. The recommendations apply to data submitted in a pre-Emergency Use Authorization (pre-EUA), an EUA request, or to tests offered under an applicable enforcement discretion policy; the FDA is accepting comments on the draft through March 10, 2025.
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