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ODE Director Tillman resigns

This article was originally published in The Silver Sheet

Executive Summary

Office of Device Evaluation (ODE) Director Donna-Bea Tillman will step down March 26 to join Microsoft's health unit, she said in a March 1 e-mail to her staff. Tillman, a biomedical engineer and 15-year ODE veteran, has led CDRH's pre-market review office since 2004. She will soon be the director of regulations and policy for Microsoft's Health Solutions Group, which develops health information technology products. Pressure on Tillman has grown in recent years in the face of complaints by lawmakers, patient advocates and some internal staff at ODE that the device review process has become too lenient and that device center management is too close to industry ("The Silver Sheet" January 2009). However, Tillman gave no sign in her e-mail that she was in any way pressured to resign, and she expressed full confidence in the current device review process. Christy Foreman, ODE's deputy director for engineering and science review, will temporarily serve as office director while a permanent replacement is sought, the agency said. Foreman, also a biomedical engineer, has been with CDRH since 1996
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