The U.S. Food and Drug Administration said it will take a less restrictive approach to real‑world evidence for device premarket applications, allowing sponsors to use large datasets that lack individual patient‑level data in support of labeling expansions. The guidance aims to make it easier for manufacturers to submit RWE from registries and aggregated sources. Regulators framed the move as enabling broader use of existing clinical and outcomes data while maintaining safety standards; manufacturers responded that the policy could lower costs and speed indication expansions. The shift also signals the FDA’s continued emphasis on pragmatic evidence sources for regulatory decisions across product classes.