The U.S. Food and Drug Administration signaled a less restrictive stance on real‑world evidence (RWE) by issuing guidance that premarket device applications need not include identifiable individual‑level patient data from real‑world sources. The agency said it will consider harmonizing similar updates for drug and biologic submissions. Regulators’ move lowers one barrier for companies seeking label expansions and postmarket surveillance strategies that rely on registries and aggregated data. It may speed approvals and broaden the evidence base manufacturers can use, but also raises privacy and validation questions about aggregated dataset provenance and analytical rigor. Industry executives and regulators will now focus on standards for data curation, endpoint definition, and statistical approaches to ensure RWE is fit for regulatory decision‑making.