Deep Dive
Let's Talk Risk! Podcast
Deep Dive: FDA's RWE Guidance
- Published
- July 24, 2026
- Duration
- 20:51
- Summary source
- description
- Last updated
- Aug 19, 2026
Discusses Real-world data does not become regulatory evidence simply because it is large, current, or readily …
Summary
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 evidenc…
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Show notes
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-