FDA Update – January 17, 2025

FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency

The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that tests for new and unknown diseases are accurate and reliable, even when developed under urgent circumstances. Below are some key takeaways from the draft guidance document:

• Focus on public health emergencies: This guidance specifically addresses situations where the Secretary of Health and Human Services has declared a public health emergency, such as the COVID-19 pandemic.
• Validation is crucial: The guidance emphasizes the importance of thoroughly validating tests to ensure they can accurately detect the emerging pathogen and aid in diagnosis.
• Recommendations for validation studies: The FDA provides detailed recommendations for conducting validation studies, including the types of studies needed and the data to be collected. This includes evaluating clinical performance using at least 30 positive and 30 negative specimens compared to a highly sensitive comparator method (often a molecular test).
• Flexibility for early stages: Recognizing that a suitable comparator may not be readily available in the early stages of an outbreak, the guidance allows for initial validation using contrived samples.
• Templates available: The FDA has also released a generic template to help manufacturers prepare and submit EUA requests for their tests.
• Flexibility and collaboration: The guidance acknowledges that different outbreaks and test technologies may require flexibility in the validation process. The FDA encourages manufacturers to consult with the agency for guidance on alternative approaches.

Having accurate and reliable diagnostic tests is essential for responding to public health emergencies. This guidance will help ensure that tests for emerging pathogens are developed and validated effectively, enabling faster diagnosis, better patient care, and more effective public health interventions.

For the original FDA update, please visit the FDA’s website.

We are dedicated to navigating this industry diligently, underscoring our unwavering commitment to you, our valued clients. As always, your trust in mdi Consultants drives us to continually improve and deliver excellence in every aspect of our operations.

mdi was involved in dealing with the FDA during Covid crisis and worked closely with the FDA for our clients.

Questions?

For any further questions for validation of IVD devices and how to approach an EUA request, please email mdi Consultants at [email protected] RE: IVD/EUA.