Surrogate samples, when properly used, can not only decrease the time needed for analytical testing, but also reduce the costs and time of sample collection for development and regulatory submission. But the lack of commonly agreed to terminology and a defined experimental framework for surrogate use reduces the predictability and efficiency of IVD development, translating into higher costs and reduced patient access to new and innovative medical devices.
The framework — created via a 22-month collaborative process between MDIC, FDA CDRH, AdvaMed, BD, Abbott, Hologic, Sysmex, Roche, and BARDA — aims to establish a foundation for the use of surrogate samples to support IVD product development and the regulatory process. The framework may be found here.
Harmonized educational materials were created for IVD test developers and FDA CDRH reviewers to facilitate a more predictable pathway for submissions. These educational materials include a Surrogate Sample Framework Training Module and five case studies.