The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications.
Under new guidance issued Dec. 15, the agency said it will accept real-world evidence without requiring the inclusion of identifiable individual patient data in marketing submissions for some devices, according to a news release. The FDA said it also plans to consider similar updates for drug and biologic applications.
Historically, the agency required patient-level data to consider real-world evidence in regulatory submissions. The updated stance acknowledges that large datasets — such as hospital records, disease registries and insurance claims — may offer valid insights without disclosing private patient information.
Since 2016, 35 drugs, biologics or vaccines have included real-world evidence in applications. Device approvals have featured more widespread integration, with more than 250 premarket authorizations using real-world evidence in the same time frame.
FDA Commissioner Marty Makary, MD, said the policy aims to unlock access to vast databases such as cancer and cystic fibrosis registries that contain critical insights about how treatments work in the real world.
