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FDA targets medical device safety in new plan

Executive Director - Thursday, April 19, 2018

  • FDA Commissioner Scott Gottlieb on Tuesday released an agenda aimed at enhancing medical device safety and innovation in the U.S.
  • The five-pronged Medical Device Safety Action Plan is built around a total product life cycle approach that calls for integrating the Center for Devices and Radiological Health’s (CDRH) premarket and postmarket offices across functions.
  • The plan comes as first-in-kind products are reaching the market. Last year, the FDA approved the first automated insulin delivery device for type 1 diabetes and a blood test to evaluate traumatic brain injury.

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