Former FDA Director, AAMI Board Member Dies at 87


Posted January 10, 2018

David Link
David Link

Pioneering medical device regulator and early AAMI leader David Link died on Dec. 23, 2017 in Massachusetts General Hospital. He was 87.

Link was hailed for his “common-sense” approach to regulation at the Food and Drug Administration (FDA) and for his pioneering role in developing strong ties between the agency and AAMI.

Although Link, who earned degrees in physics and business, never attended medical school, his career was focused on medical devices, most significantly as the first director of the FDA’s Bureau of Medical Devices, which would eventually become the Center for Devices and Radiological Health. From 1974–1980, Link set the tone for medical device regulation by ushering critical amendments through Congress and providing essential guidance in the areas of quality control and validation.

Link’s approach to regulation was applauded by many in the burgeoning medical device industry.

“As a member of the senior management of one of the companies to which the Medical Device Amendments of 1976 would surely apply, there was great concern about the implementation of the act and the almost certain draconian regulations to follow,” said Ed Duffie, Jr., now retired. “But, mirabile dictu, David Link and his associate, Larry Pilot, were a breath of fresh air. They clearly had a mandate to keep the American public safe from harm due to medical devices of all sorts, but their attitude in doing so was not to be overly burdensome to the industry nor overly costly to its customers. Their common-sense, even-handed approach to implementing the new law was a welcome change from the regulatory atmosphere surrounding most other administrative agencies.”

During his time at the FDA, Link forged a strong partnership between the agency and AAMI.

“Dave’s close collaboration with AAMI during this period resulted in the successful early growth and international visibility of AAMI to the satisfaction of the device industry and healthcare community,” said Pilot, an attorney and expert on medical device regulations.

Such partnerships between the government and nonprofit organizations were not common at the time, according to Mike Miller, who served as AAMI’s president and CEO for the association’s first 40 years.

“David, unlike many regulators, was willing to roll up his sleeves and work closely with nonprofit associations such as AAMI that cooperatively could develop and implement programs that could be utilized by the FDA, among others, to implement its regulatory activities to the benefit of all AAMI members and the public,” Miller said. “He often did so when his actions might not be popular with some segments in the medical device field. In that respect, he ignored the impediments of unnecessarily rigorous conflict-of-interest thinking.”

Link was a member of AAMI’s Board of Directors for many years, played an active role in AAMI’s standards program, and chaired AAMI’s government relations committee.

“One of the most important contributions that David made to AAMI was his and the FDA's support for AAMI assuming the national and international secretariats for medical device sterilization activities,” Miller said. “This activity, in my opinion, was one of the most pivotal achievements in AAMI's history, leading to new areas of membership, major new educational and publications programs, important new areas of standards development and an impressive new presence in national and international arenas.”

After leaving the FDA, Link went on to manage the regulatory affairs, quality assurance, sales, and manufacturing functions at Cordis, Millipore, and Expertech, and served as an industry consultant for Boston Healthcare Associates.

A memorial service will be held at St. Andrew’s Episcopal Church in Wellesley, MA on Jan. 20 at 1:30 p.m. The family asks that in lieu of flowers, donations be made to the Appalachian Mountain Club or the Jane Goodall Institute.