Deep Dive: FDA's RWE Guidance

Let's Talk Risk! Podcast · Jul 24, 2026 · 20m · transcript

Real-world data does not become regulatory evidence simply because it is large, current, or readily available.

FDA’s December 2025 final guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, supersedes the 2017 guidance and provides a more detailed framework for determining when real-world data can generate evidence suitable for a medical device regulatory decision.

One important change is FDA’s recognition that a sponsor’s inability to obtain participant-level data does not automatically prevent the Agency from evaluating the evidence. But this…