FDA Issues Draft Guidance On Real-World Evidence For Medical Devices

The US FDA is clarifying how it evaluates real-world data when making regulatory decisions on medical devices.

Real World Data
• Source: Shutterstock

The Food and Drug Administration draft guidance published on 19 December explains how the agency determines if real-world data (RWD) is sufficient for generating real-world evidence (RWE) that can be used when making regulatory decisions on medical devices.

The document, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” expands recommendations to the 2017 guidance,...

Welcome to Medtech Insight

Create an account to read this article

More from Regulation

More from Policy & Regulation

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.