Key Digital Health and Device Leaders Depart FDA Amid Regulatory Challenges

A tumultuous year at the Food and Drug Administration will be capped off at the agency’s devices center with the departure of two key leaders, just as regulators are sorting through challenges related to artificial intelligence and launching new initiatives on software as a medical device regulation.

Sources indicate that Jessica Paulsen, a 15-year veteran of the FDA and acting deputy director of its Digital Health Center of Excellence, is leaving the agency. She has been leading the center since last summer when her predecessor, Sonja Fulmer, departed for the Mayo Clinic. Fulmer had taken over from Troy Tazbaz, who left in January to return to Oracle. The center plays a crucial role in communicating with industry and developing guidance relevant to digital health. Additionally, David McMullen, director of the FDA’s office of neurological and physical medicine devices, has been poached by Neuralink, Elon Musk’s brain-computer interface company. McMullen’s office is responsible for regulating Neuralink and has been pivotal in discussions surrounding the future of regulatory frameworks.

The loss of Paulsen and McMullen comes at a critical juncture for the FDA, particularly as the agency faces increasing demands for oversight in the rapidly evolving landscape of digital health technologies. A recent Government Accountability Office report highlighted that insufficient staffing limits the FDA’s ability to conduct effective oversight, raising concerns about the agency’s capacity to manage new technologies and initiatives. As the FDA gears up for new regulatory responsibilities, the departures of these leaders may hinder its ability to adapt and respond to the complexities of AI in healthcare.