On December 2025, FDA published a final (nonbinding) guidance: “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” It clarifies how FDA assesses RWD quality to determine whether resulting RWE can support regulatory decisions, and it supersedes the 2017 guidance.
The guidance highlights:
- Relevance & reliability assessments (what FDA expects sponsors to evaluate and describe)
- Considerations for methods and study design when using RWD to generate RWE
- Submission documentation to support FDA review (e.g., protocol and relevance/reliability assessment reporting)
A practical note that FDA and industry may need up to 60 days to operationalize the recommendations.
More info here.