Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration has issued a significant policy change aimed at expanding how real-world evidence is used in regulatory reviews of drugs and medical devices. On December 15, 2025, the agency announced updated guidance that removes a longstanding requirement for identifiable individual patient data in many real-world evidence (RWE) submissions. This shift is expected to make it easier for sponsors to use large, de-identified healthcare datasets in applications and could speed up access to safe and effective treatments.
What Changed
Real-world evidence comes from data collected outside traditional clinical trials, including electronic health records, insurance claims, disease registries, and hospital systems. Until now, the FDA generally required RWE submissions to include identifiable patient-level information. That requirement limited the use of extensive, de-identified datasets that could offer insight into how products perform in everyday clinical settings.
Under the new guidance, the FDA will accept RWE for certain medical device applications even if it is derived from de-identified data. The agency will evaluate the strength and relevance of RWE on a case-by-case basis, rather than dismissing it solely because it does not include identifiable patient information. The FDA also said it plans to consider similar updates for drug and biologic guidance.
FDA Commissioner Martin Makary said, “We’re removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster.” He further highlighted that removing this barrier will help unlock large databases such as national cancer and cystic fibrosis registries, claims databases, and aggregated electronic health record systems. These sources can offer broader insights into treatment outcomes across diverse patient populations and real clinical settings, complementing evidence from clinical trials.
Impact on Drug and Device Development
Since the 21st Century Cures Act and the launch of the FDA’s Real-World Evidence Program, the agency has encouraged the use of RWE to support regulatory decisions. However, adoption has been uneven across product types. Since 2016, only 35 drug applications have incorporated real-world evidence, while medical devices have seen over 250 premarket authorizations supported by RWE during the same period. This contrast highlights how procedural and data-related barriers have limited RWE use in drug reviews compared with devices, despite similar potential benefits.
By opening the door to de-identified data sources, the FDA wants to lower a practical hurdle that sponsors and data scientists have long cited. Large, privacy-protected datasets may now contribute more meaningfully to regulatory submissions. This could help companies demonstrate product effectiveness and safety in broader patient populations and real practice environments, not just controlled clinical trials.
Looking Ahead
The FDA’s move reflects a broader trend toward modernizing regulatory science and evidence standards. Accepting robust de-identified RWE may improve regulatory decision-making, enhance post-market monitoring, and encourage more efficient development paths. Sponsors will need to ensure the quality and relevance of the RWE they submit, but the updated approach gives them more flexibility in how they support their applications.
This policy change does not replace randomized controlled trials where they are needed, but it does expand the tools available to innovators and regulators. Over time, it could help bring new therapies and devices to patients faster and with a richer understanding of how they perform across real-world use cases.
This direction also aligns with the FDA’s broader emphasis on Technology-Enabled Meaningful Patient Outcomes (TEMPO) in medical device evaluation, which encourages the use of digital technologies and real-world data to capture outcomes that matter most to patients in everyday clinical settings.
References
FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews, 15 December 2025, https://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews
U.S. Food and Drug Administration. Real-World Evidence Program. US FDA; updated periodically. 22 September 2025, https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
U.S. Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and FDA staff. US FDA; 31 August 2025, https://www.fda.gov/media/99447/download
U.S. Food and Drug Administration. Framework for FDA’s Real-World Evidence Program, December 2018, https://www.fda.gov/media/120060/download
FDA Moves Towards Real-World Evaluation of Digital Devices With TEMPO Program, Pharmacally, 06 December 2025, https://pharmacally.com/fda-moves-toward-real-world-evaluation-of-digital-devices-with-tempo-program/