The inspectors who walk through the factories where American medicines and medical devices are made are set to stop specializing by product type, under a reorganization the Food and Drug Administration will implement across the agency beginning October 1.
The plan, known internally as Simple Reform, would merge the food and beverage, medical device, and clinical research inspectorates so that specialized field inspectors operate as generalists across multiple industries, and centralize administrative functions under a shared-service model. The changes were approved and communicated in an internal agency announcement reviewed by NOTUS from Melanie Keller, the agency's deputy commissioner for operations, and the FDA issued a Federal Register notice announcing the reorganization on July 29.
