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# Medical Device RWE Guidance
- URL: https://www.fdaweb.com/medical-device-rwe-guidance/
- Published: 2025-12-17T12:00:00.000Z
- Updated: 2026-09-14T15:29:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160405

FDA has published a guidance, *Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices*, clarifying how the agency evaluates real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. The [document](https://www.fda.gov/media/99447/download?ref=fdaweb.com) applies to all medical devices as the term is defined in the Federal Food, Drug, and Cosmetic Act, including software that meets the definition of a medical device.

The guidance is part of FDA's announcement [this week](https://www.fdaweb.com/restrictions-on-real-world-evidence-regulatory-reviews-eased/) that it is removing a long-standing barrier to the use of real-world evidence (RWE) in regulatory reviews. “In new guidance for certain types of medical device submissions, the agency states it will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission,” FDA said in a [notice](https://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews?utm%5Fmedium=email&utm%5Fsource=govdelivery). “The FDA similarly intends to consider updating its guidance for drugs and biologics.”

The change addresses a concern raised for years by industry and data scientists that FDA’s insistence on access to private, patient-level data has effectively excluded many large, high-value datasets from regulatory use. Those requirements made it impractical to leverage national registries, insurance claims databases, and other large-scale sources that contain aggregated or de-identified information, FDA says.

The guidance includes an Introduction and Scope, Background, Real-World Evidence, Regulatory Context in Which RWE May be Used, Characteristics of Real-World Data, Examples Where RWE is Used, and Glossary.