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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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The Medical Device Innovation Consortium (MDIC) has proposed a framework that medtech sponsors can use when collecting real-world evidence (RWE) to support product applications to the US Food and Drug Administration. When finalized, the document aims to be a blueprint that can help accelerate certain devices and diagnostics to market.

The MDIC on 21 January published a draft document titled the “External Evidence Methods (EEM) Framework” that lists external data...

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