The U.S. Food and Drug Administration announced a less restrictive stance toward device premarket submissions that use real‑world evidence (RWE) lacking patient‑level data, potentially lowering the bar for device manufacturers seeking label expansions. The change is aimed at broadening acceptable RWE sources while maintaining standards for safety and effectiveness. Separately, FDA Commissioner Marty Makary told a Wall Street audience the agency will consider more real‑world data across regulatory decisions and reiterated calls to reform early‑phase clinical trials. Together the moves signal an agency push to integrate observational datasets into regulatory pathways, though sponsors will still need to justify data provenance and analytical rigor. RWE here refers to clinical data collected outside traditional randomized trials, such as registries and health‑system datasets.