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 sources as well as novel statistical methods that can help...