Leadership Changes and Structural Shifts at FDA's Device Center

The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is undergoing significant leadership changes, with the departure of another senior official and recent organizational restructuring. These developments come at a critical time for the agency, as it navigates new user fee agreements and implements innovative programs to streamline device approvals.

High-Profile Departure and Recent Hires

Douglas Kelly, deputy center director for science at CDRH, announced his immediate departure in a LinkedIn post on Sunday. Kelly, who joined the FDA in 2020 after a career in venture capital, played a crucial role in negotiating the latest user fee agreement and establishing new programs within the center.

During his tenure, Kelly was instrumental in recruiting industry leaders to key positions at the FDA. Notable hires included Ross Segan, who joined from Olympus in September as director of the Office of Product Evaluation and Quality, and Troy Tazbaz, who left Oracle to lead CDRH's Digital Health Center of Excellence.

However, these recent appointments have been short-lived. Tazbaz left the agency in late January, while Segan was terminated in a recent wave of cuts targeting probationary employees with less than two years of service at the FDA.

Organizational Restructuring and Program Initiatives

Kelly's tenure at CDRH was marked by several significant initiatives aimed at improving the device approval process and enhancing collaboration with industry stakeholders. A key achievement was the establishment of the Total Product Lifecycle Advisory Program, which allows developers of breakthrough devices to engage earlier with FDA review teams and external stakeholders.

The latest user fee agreement, which Kelly helped negotiate, authorizes the FDA to collect up to $1.9 billion in fees from the medical device industry from 2023 to 2027. This funding is critical for maintaining and enhancing the agency's review capabilities and supporting new programs.

Uncertainty and Next Steps

The recent leadership changes and organizational restructuring at CDRH have created uncertainty within the agency and the medical device industry. While the FDA has reportedly reinstated some of the recently fired employees, it remains unclear whether key figures like Ross Segan have been offered their positions back or have returned to the agency.

As the CDRH continues to adapt to these changes, industry observers will be closely watching how the center's operations and priorities may shift under new leadership. The impact of these developments on ongoing initiatives, such as the Total Product Lifecycle Advisory Program and the implementation of the new user fee agreement, remains to be seen.