The Food and Drug Administration’s medical device division has experienced another high-level departure with the resignation 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 exit from the role.
Kelly, who brought experience from the venture capital sector, began his FDA tenure in 2020, working under then-director Jeff Shuren before transitioning to report to Michelle Tarver, who assumed leadership of the device center in October. During his time at the agency, Kelly played a crucial 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 manufacturers between 2023 and 2027.
Among Kelly’s notable accomplishments 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 leadership also proved instrumental in bringing key industry figures into the FDA’s fold.
Two of Kelly’s significant recruitment successes included Ross Segan, who transitioned from Olympus to become director of the Office of Product Evaluation and Quality, and Troy Tazbaz, who departed Oracle to head the CDRH’s Digital Health Center of Excellence. However, both appointments faced unexpected turns: Tazbaz resigned in late January, while Segan was among those affected by a wave of terminations targeting employees still in their probationary period.
The FDA has since taken steps to reverse some of these staff cuts, though the agency, along with the Department of Health and Human Services, has remained silent on queries regarding Kelly’s departure and Segan’s potential reinstatement or return to the organization.
This latest leadership change occurs amid a period of significant personnel shifts at the FDA, particularly within its device regulation division. The departures of key figures like Kelly, Tazbaz, and the temporary loss of Segan have raised questions about the stability and continuity of leadership within the agency’s medical device oversight operations.
The CDRH plays a vital role in ensuring the safety and effectiveness of medical devices in the United States, making these staffing changes particularly noteworthy for the healthcare industry. Kelly’s departure, following his relatively brief but impactful tenure, marks another significant transition for the agency as it continues to navigate its regulatory responsibilities and relationship with the medical device industry.
The user fee agreement that Kelly helped negotiate remains a cornerstone of the FDA’s device review funding, ensuring the agency can maintain its oversight capabilities through 2027. His work on the Total Product Lifecycle Advisory Program also leaves a lasting legacy, creating improved pathways for innovation in medical device
development.
These recent developments at the FDA underscore the ongoing challenges faced by regulatory agencies in maintaining consistent leadership while fulfilling their crucial public health mission. The
reinstatement of some previously terminated staff members suggests an acknowledgment of the importance of maintaining institutional knowledge and expertise within the organization, though questions remain about the long-term impact of these personnel changes on the agency’s operations and effectiveness in overseeing medical device safety and innovation.