FDA Aims to Speed Up Medical Device Approval

The new Innovation Pathway could conduct premarket reviews of products within 150 days, nearly half the time it currently takes.

On Feb. 9 the U.S. Food and Drug Administration proposed the Innovation Pathway, which is a priority review program for new, breakthrough medical devices.

The new program is part of a broader effort underway in the FDA's Center for Devices and Radiological Health designed to encourage cutting-edge technologies among medical device manufacturers, the government said.

Proposed actions include:

  • establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a products development and clinical testing stages
  • creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators
  • using more device experience and data collected outside the United States

The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.

AP reported Mark Leahey, president of the Medical Device Manufacturers Association commenting on the new initiative: "Unnecessary and unreasonable delays for safe and effective products not only hurt innovation, they unfairly punish patients who are relying on America's med-tech entrepreneurs for help."

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.

For more see the CDRH Medical Device Innovation Initiative.

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