The FDA announced a policy shift Dec. 15 to ease requirements for real‑world evidence (RWE) used in device premarket applications — specifically, the agency will not require identifiable individual‑patient data from certain real‑world sources. The agency indicated it intends to update guidance for drugs and biologics similarly. Regulators say the change aims to increase the use of high‑quality RWE in regulatory decisions while protecting privacy and data utility. The move could lower the bar for manufacturers to supplement clinical trial data with broad real‑world datasets, potentially accelerating label expansions and postmarket evaluations. Clarification: RWE refers to clinical evidence derived from real‑world data sources such as registries, claims, and electronic health records rather than randomized controlled trials.