MDIC Proposes Real-World Evidence Framework For Sponsors To Hasten Product Applications
Executive Summary
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...
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.
21st Century Cures: Device Provisions
Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.
FDA Scolds Firms For Claims That Could Mislead The Public About COVID-19 Products
The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: