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FDA Launches Medical Device Innovation Initiative
Date:2/8/2011

ve medical devices that reduce suffering and treat previously untreatable conditions," said CDRH Director Jeffrey Shuren, M.D., J.D. "CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs."

The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic designed to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis. DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project.

The proposed Innovation Pathway program includes the following features:

  • products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
  • selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
  • products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and deter
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SOURCE U.S. Food and Drug Administration
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