The U.S. FDA has removed a long-standing barrier to using real-world evidence (RWE) in regulatory reviews — a move that could reshape how data are evaluated for medical devices and, potentially, drugs. The change signals the agency’s growing openness to data beyond traditional clinical trials, FDA officials say.

Under new guidance for certain medical device submissions, the FDA will no longer require identifiable, individual-level patient data for RWE in every marketing application. Similar updates may follow for drugs and biologics, potentially speeding innovation and approval timelines across multiple therapeutic areas.

RWE has long been touted as a way to modernize regulatory decision-making, but stringent FDA expectations have limited its use. Since 2016, only 35 drugs, biologics, or vaccines have incorporated RWE, while device submissions have leaned more heavily on it — over 250 premarket authorizations during the same period — though growth has slowed in recent years.
A key obstacle has been the FDA’s insistence on patient-level data, effectively excluding large-scale data sets that could provide population-level insights without exposing identifiable information. Real-world data sets reveal treatment effectiveness, safety, and patient diversity; dimensions often missed in traditional trials.

The updated guidance reflects growing consensus among sponsors, regulators, and data scientists: meaningful conclusions can be drawn from some real-world data sets without compromising privacy. FDA reviewers will now evaluate the quality, rigor, and relevance of submitted RWE on a case-by-case basis.

“We’re removing unnecessary barriers that have limited our ability to use powerful real-world evidence to bring life-changing treatments to patients faster,” FDA Commissioner Marty Makary, M.D., MPH, said, highlighting large registries as an underutilized source of clinical insight.

The FDA said the policy change opens the door to broader use of deidentified data sets containing millions of patient records; from national cancer registries to hospital databases, insurance claims, and electronic health records. These resources track outcomes across diverse populations and real-world care settings, dimensions traditional clinical trials often struggle to capture.

Analysts say the move could also encourage more consistent RWE standards, helping sponsors generate data regulators can trust.

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