FDA allows de-identified RWE in device submissions
- On December 18, 2025, the U.S. Food and Drug Administration issued final device guidance allowing some real-world evidence submissions without identifiable patient-level data. (fda.gov) - FDA Commissioner Marty Makary said the change would “unlock access” to databases containing millions of patient records, including cancer registries and claims datasets. (fda.gov) - Since February 17, 2026, sponsors have generally been expected to include the newly recommended information in device submissions under the final guidance. (fda.gov)
The U.S. Food and Drug Administration did not issue this policy on May 15, 2026. The agency released the final guidance on December 18, 2025, and said at the time it would accept real-world evidence in certain medical device submissions without always requiring identifiable individual patient data. The document updated and superseded the FDA’s 2017 guidance on the same topic, according to the agency’s guidance page. (fda.gov) Drug Discovery News published a May 14, 2026 article summarizing the policy after the FDA had already finalized it. ### What changed in the FDA’s policy? The December 18, 2025 guidance said FDA reviewers may consider real-world evidence generated from some de-identified data sources on an application-by-application basis rather than requiring identifiable patient-level records in every case. (fda.gov) The FDA described that shift as the removal of a “key limitation” on the use of real-world evidence in drug and device application reviews. (fda.gov) Marty Makary, the FDA commissioner, said in the agency’s December 15, 2025 press release that the change would remove “unnecessary barriers” and open access to large databases, including cancer and cystic fibrosis registries, hospital system databases, insurance claims databases and electronic health record networks. (drugdiscoverynews.com) (fda.gov) ### Which submissions does the guidance cover? The final document is titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” and the FDA said it applies to sponsors and staff considering the use of real-world evidence in regulatory submissions for medical devices. (fda.gov) The guidance was issued by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. The FDA said the guidance clarifies how it evaluates real-world data to determine whether those data are of sufficient quality to generate real-world evidence for device decisions. The agency also said the document contains expanded and updated recommendations for sponsors seeking to use that evidence in submissions. (fda.gov) ### How much has FDA already used real-world evidence in device reviews? The FDA said more than 250 device premarket authorizations included real-world evidence from 2016 through the date of its December 2025 announcement. (fda.gov) The same release said 35 drugs, biologics or vaccines had included real-world evidence in applications over that period. Daniel Caños, director of the Office of Clinical Evidence and Analysis at CDRH, and Michelle Tarver, director of CDRH, wrote in an FDA Voices post that the agency later published 73 examples of marketing authorizations using real-world evidence from fiscal years 2020 through 2025. (fda.gov) They said those examples span the product life cycle and include data from registries, electronic health record aggregators, claims and billing data, device-generated data and digital health platforms. (fda.gov) ### Why are de-identified datasets a focus? The FDA said its earlier approach had made it impractical to use many large databases because the agency had historically insisted that submitted real-world evidence include private, confidential information at the individual patient level. (fda.gov) The agency said some large data sources can still yield meaningful evidence without submitting identifiable records. (fda.gov) The December 2025 press release cited national cancer registries, hospital systems, insurance claims databases and electronic health record networks as examples of sources that could now be more usable in submissions. (fda.gov) ### When do sponsors have to follow the updated recommendations? The FDA told industry in a February 18, 2026 town hall that the final guidance carried a 60-day transition period. The agency said that beginning on February 17, 2026, it generally anticipated sponsors would be ready to include the newly recommended information in submissions, though it would review that information if sponsors submitted it earlier. (fda.gov) The docket for comments on the guidance is FDA-2023-D-4395, according to the final document, and the FDA said comments may be submitted at any time through Regulations.gov for consideration in a future revision or update. (fda.gov 1) (fda.gov 2) (fda.gov 3)
