June 1, 2026
Health Care Law Today
FDA’s One-Day Inspectional Assessments Pilot: A Risk-Based Shift in Oversight — What Regulated Entities Need to Know and How to Comply
On May 6, 2026, the U.S. Food & Drug Administration (FDA) announced the launch of a pilot program for one-day inspectional assessments — a new, streamlined screening tool designed to make the agency’s inspectional resources more targeted and efficient. Then former FDA Commissioner Marty Makary, M.D., M.P.H., described the initiative as a way to “strengthen our inspectional approach by focusing our time and resources where they are most needed,” while minimizing operational disruption for lower-risk establishments. There is no indication from FDA that this initiative will change after Commissioner Makary’s recent resignation.