By: Anya Bekhtel, Mittal Consulting

‘With this new finalized guidance document, FDA has eliminated the requirement for real world evidence (RWE) supplied in marketing applications to mandatorily include identifiable, individual patient data, opening a host of datasets for use that were previously inadmissible.‘

On Monday December 15, 2025, the FDA announced that the Agency is removing a key limitation on the use of Real-World Evidence (RWE) in drug and device marketing submissions.

RWE consists of routinely collected Real-World Data (RWD) regarding patient health status and/or the delivery of health care, including information from electronic health records, medical claims, product or disease registries, or third-party digital-health technologies.¹ In 2016, the 21^st Century Cures Act established a framework for use of RWE in regulatory decision-making, with over 250 medical devices utilizing RWE in their marketing submissions since the Cures Act went into effect.²

However, FDA reports that RWE-based authorizations have plateaued in the last few years, potentially as a result of FDA’s burdensome expectation that Sponsors utilize only RWE with identifiable individual patient data. This requirement made it challenging for Sponsors to successfully utilize large, multi-region datasets to support their marketing claims, and significantly restricts the practical utility of RWE.

With FDA’s recent announcement, the Agency will now accept RWE without identifiable individual patient data. FDA’s update creates an opportunity for Sponsors to leverage large-scale databases with millions of patient records, including the National Cancer Institute’s Surveillance, Epidemiology, and End Results, hospital systems databases, insurance claims databases, and electronic health record networks.²

This change will be incredibly valuable for Sponsors planning submissions in the oncology and rare disease spaces, as it enables use of cancer registries to better assess how real, complex treatment regiments impact overall patient outcomes. FDA’s RWE policy change can help reduce the clinical testing burden on Sponsors and accelerate the time and cost of obtaining market access.  

Even with this change, Sponsors should still consult FDA’s draft guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices and utilize recommended data relevance, data reliability, and RWD documentation techniques to best support a successful marketing submission.

References:

1. U.S. Food and Drug Administration. Real-World Evidence. FDA website. Accessed December 17, 2025. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
2. U.S. Food and Drug Administration. FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews. FDA website. Accessed December 17, 2025. https://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews