The medical device community mourns the passing of Larry Pilot, an extraordinary legal mind and a pioneer in medical device regulation, who peacefully passed away this February, 2025. With a career spanning more than five decades, Pilot left an indelible mark on the field of medical device law, shaping the regulations that continue to safeguard patient safety and encourage technological innovation. His dedication, wisdom, and unwavering commitment to the advancement of medical devices will be remembered and cherished by colleagues, friends, and the many professionals whose careers he influenced.

Pilot’s journey in regulatory law began in 1969 when he joined the Department of Health, Education, and Welfare. Soon after, he transitioned to the Food and Drug Administration (FDA) as Special Assistant to Commissioner Charles C. Edwards. In this role, he played a crucial part in laying the foundation for the regulation of medical devices, a sector that was then in its infancy. Of note, following a 1970 AAMI special report on United States v. Bacto-Unidisk, highlighting products that straddled the definition of “device” and “drug,” Pilot joined David Link to survey AAMI and other stakeholders. This work laid the groundwork for the modern classification of medical devices.

"It is fair to say that, without Larry, there likely would not be an AAMI as we know it today," said AAMI vice president of Industry, Joe Lewelling.

In 1971 Pilot, alongside three other FDA colleagues, helped establish the Agency’s Office of Medical Devices, an initiative that would evolve into a critical regulatory arm of the FDA. Five years later, Pilot’s influence and position within the Agency proved instrumental in the development and implementation of the Medical Device Amendments of 1976. Recognizing his invaluable contributions, the FDA honored Pilot with its Award of Merit in 1977, a testament to his influence in regulatory policy.

After a decade of public service, Pilot transitioned into private practice in 1979. As an attorney, he represented numerous medical device manufacturers, helping them navigate the increasingly complex regulatory landscape. He also co-founded the Medical Device Manufacturers Association, advocating for policies that balanced innovation with patient safety.

Former AAMI President and CEO Mike Miller spent more than half his career working alongside Pilot and remembers him as a man of deep intellect and unwavering commitment.

“Larry strived to ensure that device regulation was constructive and not restrictive to this field. A new frame of reference for medical device regulation was created and AAMI and Larry worked hand-in-hand in developing that frame of reference,” he said. “Larry so much wanted to be part of the celebration of the 50th anniversary of the 1976 Medical Device Amendments. It was an event that was such a major part of our professional lives, and he was very proud – as he should have been – of this contribution…”

While Pilot will not be present for the Amendments’ golden jubilee, friends and colleagues will no doubt toast his name. “His contributions will be remembered and honored,” Miller added.

Of course, Pilot’s impact extended beyond medical devices. Alongside Lynne and Carol Laskin, he played a pivotal role in the passage of the Infant Formula Act of 1980 through their work with Formula Inc. This landmark legislation established, for the first time, federal quality control procedures and nutrient requirements for infant formula, ensuring the safety and nutritional adequacy of formula-fed infants across the nation.

Even after his retirement in 2008, Pilot remained active in the field. He continued practicing law independently and served as a consultant in the medical device industry. He remained a friend and thought leader for the AAMI community. In recognition of his lifelong dedication to innovation, he was awarded the Catholic University of America (CUA) Law School’s Distinguished Alumni Award in 2022.

Larry Pilot’s contributions to medical device regulation have left an enduring imprint on the healthcare industry. His life’s work has helped ensure that countless medical devices reach patients safely and efficiently, improving lives and advancing medicine. Though he is no longer with us, his influence will be felt for generations to come.

He is survived by his family, friends, and the many professionals who will carry forward his vision of a well-regulated, innovative, and patient-centered medical device industry. Colleagues, friends, and family are encouraged to leave a memory with Larry Pilot's obituary page.