FDA’s Top Device Reviewer Resigns

The U.S. Food and Drug Administration’s (FDA) top medical device reviewer, Donna-Bea Tillman, is resigning and has accepted a job with Microsoft, the agency has confirmed.

Tillman, who has worked for the FDA for 15 years, will serve as director of regulations and policy for Microsoft.

Her decision comes amid many changes at the agency, including a new commissioner, head of the Center for Devices and Radiological Health, a review of the 510(k) process, in addition to complaints by FDA scientists last winter that the medical device process was flawed.

Janet Trunzo, executive vice president for technology and regulatory affairs at the Advanced Medical Technology Association in Washington D.C., said: “Donna-Bea Tillman has served the nation for 15 years helping ensure the safety and effectiveness of medical devices and diagnostics first as a staffer and then as director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.”

Christy Foreman, deputy director for engineering and science review, will serve as acting director of the Office of Device Evaluation while the agency begins a search for a permanent director.