FDA Seeks To Speed Innovative Medical Device Reviews
The proposed Innovation Pathway would fast-track premarket evaluations for breakthrough healthcare technologies.
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In an effort to help the U.S. maintain its position as the world leader in medical device innovation, the U.S. Food and Drug Administration (FDA) has proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices.
Announced Feb. 8, the initiative 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 program also seeks to strengthen the nation's research infrastructure for developing innovative technologies and advancing quality regulatory science.
The FDA said it is working toward conducting 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.
Jonathan Linkous, CEO of the American Telemedicine Association, told InformationWeek the new initiative can help companies in the telemedicine industry improve the process of bringing their products to market.
"The Innovation Pathway is potentially a significant move that can save time and money for companies anxious to make new and innovative telemedicine devices available to the healthcare industry and the public. It also can help startup companies and innovators in telemedicine to better understand and work with the FDA," Linkous said.
During a telephone briefing to discuss the new initiative, FDA commissioner Margaret Hamburg told reporters that the proposed Innovation Pathway has broad implications for how the FDA does business, and how the agency will continue to support important opportunities for innovation.
"This is a critical moment for innovation, for our agency, and for our nation. The pace of biomedical discovery continues to accelerate, and the stakes have never been higher," Hamburg said. "By the end of the decade a combination of trends, including international competition, will test America's role as the global leader of product in innovations and as a nation we have important choices to make about how we move forward."
The FDA plans to seek further public comment before the Pathway can be used more broadly, but has moved ahead with its first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program.