Devices

Founder of FDA Device Bureau, David Link Dies at 87

David M. Link, the founding director of FDA’s Bureau of Medical Devices (1974-80), precursor organization of CDRH, died 12/23/17 in Massachusetts General Hospital at the age of 87. A Massachusetts Institute of Technology physics graduate, Link’s career at FDA preceded formation of the Bureau, coming from Hewlett’s Packard’s device business and beginning in 1971 as director of the Office of Device Evaluation reporting to associate commissioner for medical affairs John Jennings. He later directed the new Bureau of Medical Devices and Diagnostic Products and in that capacity worked closely with device compliance director Larry Pilot and Congress in writing the 1976 Medical Device Amendments. One year after enactment, the Bureau’s name became simply the Bureau of Medical Devices.

Pilot remembers Link’s major milestones at BMD as leading FDA-Congress collaboration in establishing the device classification procedures, expert panels, and device GMP procedures which were finalized through notice-and-comment rulemaking before 1979. Under Link’s direction and reporting to/consulting with Jennings, BMD expanded from approximately 20-30 employees to several hundred when he departed in 1980. Two years later, BMD was renamed the National Center for Devices and Radiological Health; 16 months after that, the word “National” was dropped.

After leaving FDA, Link served in regulatory affairs and quality assurance positions at Cordis, Millipore, Expertech and Boston Healthcare Associates.

He is survived by his wife Shirley, son David and daughter-in-law Angelia, daughter Susan, granddaughter Samara, and his sisters Tyler and Joanne. A memorial service will be held at St. Andrews Church in Wellesley Massachusetts on Saturday, 1/20 at 1:30 pm. The family asks that in lieu of flowers, donations be made to The Appalachian Mountain Club or The Jane Goodall Institute.

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