The U.S. Food and Drug Administration announced a shift to less restrictive use of real‑world evidence (RWE) in regulatory submissions, starting with new device premarket guidance that relaxes the requirement for identifiable individual patient data from certain RWE sources. The agency indicated it intends to update drug and biologic guidance similarly. The move lowers a data‑access barrier for manufacturers and could accelerate label expansions and supplemental approvals that rely on registry, claims, and other aggregated datasets. Industry players and payers will monitor how the agency balances speed with reliability, and whether broad acceptance of de‑identified RWE changes clinical development strategies.