FDA Offers Emergency Playbook for Testing Tomorrow’s Emerging Pathogens
Published Date: 11/10/2026
Notice
Summary
The FDA just released new guidance to help companies quickly test and validate diagnostic devices for new germs during public health emergencies. This makes it easier and faster to get important tests approved or used under emergency rules, helping protect everyone sooner. If you make or use these tests, this update affects you now and could speed up your work without extra costs.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Streamlined, flexible validation requirements
The guidance consolidates and streamlines test validation recommendations across diagnostic test types, adds language emphasizing flexibility at different stages of an outbreak, and clarifies FDA's focus on collecting the most important and "least burdensome" information to submit during a section 564 declared emergency. FDA states these changes are intended to help test manufacturers better prepare for future outbreaks.
Final guidance for emergency IVD validation
The FDA issued a final guidance titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency," announced November 10, 2026. The guidance provides recommendations for validating in vitro diagnostic devices (IVDs) during a section 564 public health emergency and applies to pre-EUA submissions, EUA requests, and tests offered under an applicable enforcement discretion policy.
No new Paperwork Reduction Act collections
FDA states that the guidance "contains no new collection of information" under the Paperwork Reduction Act of 1995 and instead refers to previously approved collections with their OMB control numbers. That means the guidance does not create new OMB-approved information collections for test manufacturers.
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