On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a major policy shift aimed at enhancing regulatory pathways for drugs and medical devices. The FDA will no longer require that real-world evidence (RWE) submissions, from sources such as disease registries and electronic health records, include identifiable patient data in all cases. This change is intended to allow the use of de-identified, aggregated data to support faster, evidence-driven decisions in drug and device applications. Regulatory, clinical, and quality teams in the medical field should pay close attention to these updates, which could potentially accelerate regulatory timelines for innovative devices and treatments.
- What changed?
- How does RWE impact applications?
- What challenges are being addressed?
- FAQs
- Conclusion
- Disclaimer
- FDA Source
What changed?
The FDA has introduced new guidance that removes a key obstacle for using RWE in product reviews, particularly for medical devices. Historically, the FDA required individual patient-level data to accompany all RWE submissions, limiting the use of large, non-identifiable datasets. As of December 2025, RWE from de-identified sources such as national registries, insurance claims databases, and electronic health record networks can now be considered in reviews, dependent on the quality and relevance of the data provided. This marks a fundamental shift, enabling broader access to real-world data insights.
How does RWE impact applications?
Real-world evidence consists of data collected outside of traditional clinical trial settings and includes information drawn from medical records, patient registries, and insurance claims databases. When properly analyzed, it provides regulators with insights into how treatments function across diverse populations and real-world scenarios. In the past eight years, over 250 medical device submissions and 35 drug or biologics applications have incorporated RWE. However, barriers to accessing comprehensive datasets have slowed its widespread adoption—something this new policy seeks to address.
Expected benefits
- Accelerated access to diverse and large-scale databases
- Streamlined approval timelines for some devices and drugs
- Improved understanding of treatment outcomes in real-world scenarios
What challenges are being addressed?
Prior to this policy update, RWE submissions encountered implementation challenges due to stringent data privacy requirements. The previously required inclusion of identifiable patient-level data made it challenging to leverage large datasets that contain aggregate or anonymized information. This approach limited sponsors from fully utilizing rich real-world data sourced from registries like the National Cancer Institute’s SEER database or cystic fibrosis datasets. Experts, including data scientists and regulators, have long argued that such aggregated de-identified data still provides valuable evidence for decision-making.
FDA Commissioner Marty Makary acknowledged these challenges, stating, “We’re removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster.”
Frequently Asked Questions
- What is real-world evidence?
RWE refers to clinical data collected outside the controlled experimental conditions of a clinical trial. It is often drawn from health registries, electronic health records, and claims databases. - Does this change apply to all medical submissions?
Currently, it primarily applies to specific medical device submissions. However, the FDA is considering similar guidance updates for drugs and biologics. - Why is this update significant?
This change opens up access to large, anonymized datasets for regulatory purposes, enabling better data utilization and potentially faster approvals. - What types of data sources might sponsors now use?
Eligible sources include national cancer registries, insurance claims databases, and hospital systems databases.
Conclusion
The FDA’s new guidance represents a crucial evolution in regulatory practices, maximizing the value of real-world evidence for medical device and potentially drug approvals. By embracing de-identified datasets, the agency is enabling more efficient pathways for advancing patient care and supporting innovation. Sponsors should assess whether their RWE sources align with this updated framework.
Disclaimer
This article is for informational purposes only and does not constitute legal or regulatory advice. Professionals should consult the official guidance or seek expert counsel for specific compliance inquiries.
FDA Source
For full information about the FDA announcement, see the link below.
https://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews