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Using Surrogate Samples For IVD Trials: MDIC Issues A Framework

The group that helped developed a framework to incorporate patient preference data into regulatory device submissions has released a new document to help in vitro diagnostics sponsors tackle the problem of limited sampling by using surrogate samples. The plan has been reviewed by top FDA officials.

Developers of in vitro diagnostics (IVDs) who have difficulty collecting enough specimen to conduct necessary trials can now look to a new framework developed with assistance from officials at US FDA. The framework outlines design and selection principles for surrogate samples as well as considerations for various study types.

The Medical Device Innovation Consortium (MDIC) just released a set of recommended guidelines that have been in development since November 2015, when a working group convened to tackle questions on how to run studies using surrogate samples. The group included representatives from FDA's device center (CDRH), AdvaMed, BD Biosciences, Abbott Laboratories Inc., Hologic Inc

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