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FDA to take a more relaxed approach to the use of Real-World Evidence (RWE) in Device (and potentially drug) Application Reviews.
On December 15, 2025, the FDA published the final guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Dr. Makary said that the FDA is, “removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster.”