ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA outlines new centralized operations and announces user fee rate increases; RAPID proposal approaches; South Korea refines rules for when AI software requires a clinical study; Europe implements AI reforms; and EU expert panel opinions are assessed.
FDA Consolidates Operations
FDA is formalizing plans to centralize IT operations, communications, HR, and a range of other functions outside of the product-specific centers in a broadscale reorganization disclosed this week. “These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public,” states a July 28 Federal Register notice signed by HHS Secretary Robert F. Kennedy Jr.
The notice lists FDA’s new organizational structure office-by-office and division-by-division without explaining the key updates. HHS did not respond to a request for comment to further explain the changes, and the notice doesn’t provide an effective date for the changes.
Many of the updates appear to reflect the cuts made as part of HHS’s “reduction in force” (RIF) action in April 2025 and previously stated priorities to remove duplicative functions in each center. They also potentially overlap with a so-called “Simple Reform” that FDA says it is planning, which would consolidate its field investigative staff to be generalists that inspect any type of facility rather than product-specific specialists. However, the recent notice appears to retain the product-focused investigative offices, including the Office of Medical Device and Radiological Health Inspectorate.
Broadly, the notice appears to be the first comprehensive public listing of FDA’s post-RIF organizational structure. A few takeaways from an initial review of the document by Market Pathways:
- Functions focusing on minority health, women’s health, and pediatrics that were cut from the device and other centers are consolidated in a new agency-wide Office of Health Advancements. This will also be the new home of the Offices of Combination Products, Orphan Products Development, and Clinical Policy.
- FDA appears to have expanded its agency-wide Office of Operations to take over an array of functions, including information disclosure, travel, and human resources that was previously at least partially handled by each center.
- A new Office of Mission Information Technology Services has been created to consolidate IT functions.
- Specific pre-RIF entities within CDRH that are officially no longer part of the organization under the reorganization: the IT office and divisions, the Office of Management, and divisions within the Office of Product Evaluation and Quality for compliance and quality, post-market programs, digital health, operations, and professional development.
