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FDA ODE Director Resigns to Join Microsoft - Unclear How 510(k) Process Impacted
Rockville, MD. FDA's top medical device reviewer is resigning after 15 years with the Agency and is joining Microsoft as Director of Regulations and Legislative Affairs.
Tillman was one of several FDA officials criticized by lawmakers for their handling of the approval of a knee repair device despite repeated objections from FDA scientists who questioned its safety.
Tillman had her fans and foes. Some say the move may signal a return to slower approval times as lawmakers are increasingly concerned with the effectiveness of the entire 510(k) process, and a potential foray by Microsoft into medical technology.