The U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” This guidance outlines how FDA evaluates real-world data (RWD) and when it may be considered sufficiently reliable to support regulatory decisions using *real-world evidence (RWE).
Key highlights include:
- Clarification on how FDA assesses the relevance and reliability of real-world data sources
- Updated recommendations on study design, data collection, and analysis when using RWE in medical device submissions
- Expanded guidance that supersedes FDA’s 2017 RWE guidance, reflecting current regulatory expectations
FDA notes that implementation of the guidance may take up to 60 days following publication, and the document reflects the Agency’s current thinking but is not legally binding.
You can view the documentation here.
