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- FDA Releases Draft Guidance on Validation of IVDs
The US Drug and Food Administration (FDA) has released draft guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency. This draft guidance gives recommendations for the validation of in vitro diagnostic devices (IVDs) that test for emerging pathogens during a federally declared public health emergency. The guidance follows recommendations from two independent assessments of FDA's response to COVID-19.
The FDA also released a template to help test manufacturers understand the FDA's current thinking on test validation study data submitted as part of an Emergency Use Authorization request to the FDA.
The CAP is currently reviewing the guidance to determine its consistency with CAP policy on this issue and plans to submit comments. For emerging pathogens, like COVID-19, the CAP has advocated for laboratories to operate without the hindrance of unnecessary regulatory burden. Comments are due March 7, 2025.