MDIC Proposes Real-World Evidence Framework For Sponsors To Hasten Product Applications
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.
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Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.