Why the FDA’s new real-world evidence guidance ends the era of structured-data-only submissions

On February 17, 2026, the FDA’s final guidance on the use of real-world evidence to support regulatory decision-making for medical devices became operational. It asks sponsors to demonstrate that their real-world data is relevant, reliable, complete and traceable, for every clinical fact rather than each dataset as a whole. The first wave of submissions under the new rules is now landing at the agency, and a structural problem with how most secondary-use clinical data is built today is about to