Surrogate Sample Harmonized Education Modules

Surrogate samples, when utilized correctly, can significantly reduce the time required for analytical testing, as well as the costs and time associated with sample collection for development and regulatory submission. However, the absence of commonly accepted terminology and a clearly defined experimental framework for the use of surrogates diminishes the predictability and efficiency of IVD development, resulting in increased costs and limited patient access to new and innovative medical devices.

The framework, developed through a 22-month collaborative effort involving MDIC, FDA CDRH, AdvaMed, BD, Abbott, Hologic, Sysmex, Roche, and BARDA, aims to establish a solid foundation for employing surrogate samples to support IVD product development and the regulatory process. The framework is available here.

Harmonized educational materials have been created for IVD test developers and FDA CDRH reviewers to provide a more predictable pathway for submissions. These materials include a Surrogate Sample Framework Training Module and five case studies.