The Food and Drug Administration (FDA) has released draft guidance on how in vitro diagnostic devices (IVDs) should be validated during emergencies involving emerging pathogens, declared under Section 564. This guidance is currently in draft form and not yet ready for implementation. It gives general recommendations for testing devices to ensure they are accurate and reliable during health crises like disease outbreaks. The FDA encourages public comments on the draft by March 10, 2025, either electronically or by mail, before finalizing the guidance.
Simple Explanation
The FDA has written a draft guide to help make sure medical tests work properly during health emergencies, like new virus outbreaks, but it's not finished yet and they're asking people to share their thoughts on it by March 10, 2025.