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FDA Taps New Office of Device Evaluation Director From Industry

 
• By David Filmore

Device industry veteran John Sheets has been appointed as the new director of FDA's premarket review office for devices. It’s the second time this year that CDRH has tapped an industry executive to lead one of its offices.

FDA's Office of Device Evaluation has its first permanent director in almost two years and he comes to the post from the device industry.

John Sheets, who was most recently chief scientific officer at device and biotech firm Anika Therapeutics Inc., officially started as the director of ODE on June 12. The premarket review office has been led on an acting basis since September 2014 by William Maisel, who has also maintained his primary post as CDRH's deputy director for science, and chief scientist

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With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.