The Food and Drug Administration’s medical device division has experienced another high-level departure with the exit of Douglas Kelly, who served as deputy center director for science at the Center for Devices and Radiological Health (CDRH). Kelly made the
announcement via LinkedIn on Sunday, indicating his immediate departure from the role.
Kelly, who transitioned to the FDA in 2020 following a career in venture capital, worked under the leadership of former director Jeff Shuren and subsequently Michelle Tarver, who assumed leadership of the device center in October. During his tenure, Kelly played a pivotal role in securing the most recent user fee agreement, which authorized the FDA to collect up to $1.9 billion in fees from medical device companies between 2023 and 2027.
One of Kelly’s significant achievements was the establishment of the Total Product Lifecycle Advisory Program, an initiative designed to facilitate earlier interactions between breakthrough device
developers, FDA review teams, and external stakeholders.
His contributions to the agency included bringing in key industry figures to leadership positions. Notable appointments included Ross Segan, who joined from Olympus in September to lead the Office of Product Evaluation and Quality, and Troy Tazbaz, recruited from Oracle to head the CDRH’s Digital Health Center of Excellence.
However, both of these appointments faced subsequent challenges. Tazbaz departed from his position in late January, while Segan was among those affected by a wave of terminations targeting employees still in their probationary period – those with less than two years of service at the FDA.
In the aftermath of these staffing changes, the CDRH has moved to reinstate some of the employees who were terminated. When questioned about Kelly’s departure and Segan’s current status – specifically whether he had been offered his position back or had returned to the agency – neither the FDA nor the Department of Health and Human Services provided responses.
This latest leadership change occurs amid a period of significant personnel shifts within the FDA’s senior ranks. The departure of Kelly, who brought extensive experience from the private sector to his role at the CDRH, marks another transition in the agency’s medical device division leadership.
Under Kelly’s guidance, the CDRH implemented several initiatives aimed at streamlining the device approval process and enhancing
collaboration between the agency and industry stakeholders. His work on the user fee agreement was particularly significant, as it secured crucial funding for the agency’s device review operations over a five-year period.
The Total Product Lifecycle Advisory Program, which Kelly helped establish, represents a significant shift in how the FDA engages with developers of breakthrough devices, creating a more collaborative and efficient pathway for innovative medical technologies.
Kelly’s recruitment efforts brought experienced industry professionals into key FDA positions, although recent staffing changes have affected some of these appointments. The situation highlights the ongoing challenges the agency faces in maintaining consistent leadership and expertise while managing its regulatory responsibilities.
The impact of these leadership changes on the FDA’s medical device division remains to be seen, as the agency continues to balance its regulatory oversight duties with the need to facilitate medical device innovation. The CDRH’s recent efforts to reinstate some terminated staff members suggests an attempt to maintain stability and expertise within the organization during this period of transition.