FDA Launches Medical Device Innovation Initiative

by Sabrina I. Pacifici on February 8, 2011

News release: “Today the U.S. Food and Drug Administration proposed the CDRH Medical Device Innovation Initiative, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly. The new proposed Innovation Pathway program for pioneering medical devices, highlighted in a report published on the FDA’s website today, is part of a broader effort underway in the FDA’s Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers. The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science.”

  • Medical Device Innovation Initiative White Paper, CDRH Innovation Initiative
  • Questions and Answers about the Medical Device Innovation Initiative
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