The U.S. FDA announced a policy shift reducing constraints on the use of real‑world evidence (RWE) in regulatory submissions, starting with new device premarket guidance that will accept aggregated data sources without individual‑patient identifiers. The agency said it intends to consider parallel updates for drug and biologics submissions. Regulators will allow device applicants to use de‑identified RWE for label expansions and premarket applications, reflecting a pragmatic approach to data that complements traditional clinical trials. The move aims to lower the burden of regulatory evidence where high‑quality observational datasets exist. Manufacturers and diagnostics firms could see faster pathways for certain claims, but the change raises questions about evidentiary standards, data provenance, and post‑market surveillance. The FDA emphasized it will issue detailed guidance to set expectations for quality and traceability.