Senior FDA Device Center Leader Douglas Kelly Departs Amid Agency Restructuring

Douglas Kelly, deputy center director for science at the FDA's Center for Devices and Radiological Health (CDRH), has announced his immediate departure from the agency. The news comes as part of a series of recent leadership changes and organizational shifts within the Food and Drug Administration's medical device division.

Kelly's Tenure and Accomplishments

Kelly joined the CDRH in 2020 after a career in venture capital, reporting to former director Jeff Shuren and later to Michelle Tarver, who assumed leadership of the device center in October. During his time at the FDA, Kelly played a crucial role in several key initiatives:

• Negotiation of the latest user fee agreement, securing up to $1.9 billion in fees from the medical device industry for the period 2023-2027.
• Establishment of the Total Product Lifecycle Advisory Program, which facilitates earlier meetings between breakthrough device developers, FDA review teams, and external stakeholders.
• Recruitment of industry leaders to the FDA, including Ross Segan from Olympus and Troy Tazbaz from Oracle.

Recent Turmoil and Personnel Changes

Kelly's departure is part of a broader pattern of leadership changes at the CDRH:

• Troy Tazbaz, who was brought in to lead the CDRH's Digital Health Center of Excellence, left the agency in late January.
• Ross Segan, appointed as director of the Office of Product Evaluation and Quality in September, was among those affected by a recent wave of cuts targeting probationary employees with less than two years of service at the FDA.
• The CDRH has since reinstated some of the fired employees, though the status of Segan's position remains unclear.

These personnel changes have raised questions about the stability and direction of the CDRH. The FDA and the Department of Health and Human Services have not responded to inquiries regarding Kelly's departure or the potential reinstatement of other affected employees.

As the pharmaceutical and medical device industries continue to evolve rapidly, the impact of these leadership changes on the FDA's regulatory processes and decision-making capabilities remains to be seen. Industry observers will be closely watching for any shifts in policy or approach as the CDRH navigates this period of transition.