Deep Dive: FDA's RWE Guidance

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-07-24

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 flexibility does not lower the evidentiary bar. Sponsors must explain the limits...