The U.S. Food and Drug Administration has proposed the Innovation Pathway, a “priority review program for new, breakthrough medical devices,” the agency announced in a news release. Its 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 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.

CDRH intends to engage in formal horizon scanning—monitoring medical literature and scientific funding in a systematic way to predict where technology is heading. CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.

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 determine their appropriateness for marketing, according to the FDA

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