Devices

MDIC Releases IVD Surrogate Sample Framework

The Medical Device Innovation Consortium (MDIC) has released a surrogate sample framework for in vitro diagnostic device (IVD) development. MDUC says that when properly used, surrogate samples can decrease the time needed for analytical testing and reduce the costs and time of sample collection for development and submission.

The lack of commonly agreed to terminology and a defined experimental framework for surrogate use reduces the predictability and efficiency of IVD development, it says, translating into higher costs and reduced patient access to new and innovative medical devices.

The framework was developed over 22 months through a collaboration between MDIC, FDA, AdvaMed, BD, Abbott, Hologic, Sysmex, Roche, and BARDA and is said to aim to establish a foundation for using surrogate samples to support IVD product development and the regulatory process.

Topics include a uniform definition of a surrogate sample and glossary of terminology associated with that use, a hierarchy and points to consider when using surrogate samples, and principles and a study-specific hierarchy to guide selection of the appropriate surrogate for a specific study.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome