FDA Publishes Reorganization Centralizing Administration as Inspector Changes Loom

The Food and Drug Administration has published a revised statement of its organization, functions and delegations of authority, describing plans to "centralize and enhance key functions across the agency," in a Federal Register notice dated July 29. "These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public," the notice said.

The notice, signed by Health and Human Services Secretary Robert F. Kennedy Jr., lists the organizational units of the FDA's centers and offices, including the Center for Devices and Radiological Health, and says existing delegations of authority continue pending further orders from the commissioner. It says the Center for Tobacco Products is not part of the reorganization in light of a preliminary injunction in a pending court case.

Shared services and generalist inspectors

The plan, known as Simple Reform, was approved by the Trump administration and will take effect on Oct. 1, according to an internal agency announcement from Melanie Keller, the FDA's deputy commissioner for operations and chief operating officer, NOTUS reported on July 28.

Under the revised structure, individual centers such as the Center for Drug Evaluation and Research will no longer run their own human resources, finance and information technology. Instead, the FDA Office of Operations will control those functions across the agency under a shared-service model, NOTUS said. "Shared Services seeks to maximize efficiency and consistency," the internal FDA website detailing the plan states, according to the outlet.

The agency will also stop assigning its specialized field inspectors, who oversee the safety of medical products and clinical trials, to specific subject areas, NOTUS reported. They will instead work as generalists, conducting inspections and investigations across multiple industries. The FDA moved in 2017 to place inspectors within specific programs of expertise, and the approved plan would reverse that change, the outlet said.

No job losses, criticism from former officials

The reorganization will not drastically change the roles of the agency's nine centers and will not result in any current FDA employees losing their jobs, according to the internal agency web page, NOTUS reported. The changes formalize shifts put in place over the past 18 months, the outlet said, adding that the agency let go a total of 3,500 employees in cuts in 2025 and is now hiring about 2,200 new employees.

Former officials have criticized the plan. Steven Silverman, a former director of the Office of Compliance in the device center, wrote when the proposal was announced that "it's absurd to expect 'generalists' to develop those traits," referring to the skills and knowledge needed for inspections, according to NOTUS. Former acting commissioner Janet Woodcock had called the changes a "mindless approach" when the proposal was first announced in 2025, the outlet reported, citing Pink Sheet. The FDA did not immediately respond to NOTUS's request for comment.