VIDEO: Shuren on the FDA's new innovation track

February 10, 2011 by MassDevice staff

Dr. Jeffrey Shuren, head of the Food & Drug Administration's Center for Devices & Radiological Health, sits down for a fireside chat to discuss the agency's new "Innovation Pathway" for breakthrough medical technology.


On Feb. 8, The Food & Drug Administration unveiled a new, fast-track protocol for breakthrough medical technologies this week, saying its new "Innovation Pathway" aims to speed high-tech devices to market.

The federal watchdog agency kicked off the program by choosing a robotic arm being developed by the military as its pilot candidate, granting priority review to a Defense Advanced Research Projects Agency project to create a "brain-controlled, upper-extremity prosthetic." The DARPA team is looking to "restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation," according to the FDA.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices & Radiological health, recently sat down to discuss the new initiative with other FDA officials the media. Here's a look:

The new regulatory pathway, which is slated to undergo public review before more projects are selected, is the CDRH's push to boost the development of "pioneering medical devices" that's "designed to encourage cutting-edge technologies among medical device manufacturers."

"Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions," Shuren said in prepared remarks. "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 agency is also looking to shore up the infrastructure behind the development of breakthrough technologies. Proposed actions for the program include: