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.
You may also be interested in...
MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program
The public-private partnership has launched an initiative that aims to help regulators address digital health – in particular the US FDA’s pre-cert pathway for certain medical software.
Top FDA Officials Tout Use Of Real-World Evidence Based On New Report
The report looks at a broad range of submission and product types and concludes use of RWE/RWD has helped get new products to market faster.
New RWE Framework Aims To Get IVDs To Market Faster, Surveil COVID-19 Tests
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.