What Real-World Evidence Means for FDA Device Decisions

Speakers at The MedTech Conference in Boston said this week that broader use of real-world evidence in device regulation depends on shared standards and a change in culture, RAPS reported on Oct. 23, 2026. "There's an interesting elephant in the room when it comes to RWE: culture," said Simon Mason, chief enterprise officer of the National Evaluation System for health Technology, or NEST, according to the report.

Real-world evidence has become a regular part of device regulation. Here is what the term means and how FDA treats it.

Data versus evidence

FDA separates two terms. On its device center's real-world evidence page, real-world data are "data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources." The page lists electronic health records, registries, administrative claims data and device-generated data among those sources, along with patient-generated data, public health surveillance data and billing data. Real-world evidence is "clinical evidence regarding the usage, and potential benefits or risks, of a medical product" derived from analyzing that data.

The distinction matters because not all data qualify. FDA's final guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, issued in December 2025 by the device center and the Center for Biologics Evaluation and Research, is meant "to clarify how FDA evaluates real-world data (RWD)" and whether they are of sufficient quality to generate evidence for regulatory decisions. It supersedes the agency's 2017 guidance of the same name and covers both premarket and postmarket uses.

At the Boston session, Daniel Caños, director of the Office of Clinical Evidence and Analysis in FDA's device center, said the guidance centers on the relevance and reliability of the data, and that its principles are also reflected in ISO 14155, the good clinical practice standard for device clinical investigations, RAPS reported.

How often it is used

FDA's page counts 90 examples of real-world evidence used in device decisions in fiscal years 2012 through 2019, and 73 additional premarket examples for devices authorized in fiscal 2020 through 2025. Juan Espinoza, executive director of the Consortium for Technology & Innovation in Pediatrics, said at the session that FDA has authorized about 250 devices using real-world evidence in some form since 2016, a small share of all devices authorized in that period, according to RAPS.

FDA built NEST with outside partners to generate clinical evidence, including real-world evidence, for device evaluation. Its coordinating center works with FDA to identify high-quality real-world data sources that can be used for premarket decisions, according to the agency. FDA's fact sheet on the draft MDUFA VI user fee agreement says the next agreement would advance real-world evidence for premarket purposes, including continued support for NEST.

Not a shortcut

Speakers stressed limits. Mason said real-world evidence has value, "but it's not a way to cut corners," according to RAPS. Heather Colvin, senior director for international harmonization at Johnson & Johnson MedTech, said it should be treated as one part of a device's total clinical evidence, and that "We need to build trust by building a more standardized approach to good real-world evidence research."