VIDEO: Shuren on the FDA’s new innovation track

FDA

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:

  • “Establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product’s 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 U.S.”

CDRH said it also plans to “engage in formal horizon scanning” by keeping tabs on medical literature and scientific funding. Projects tapped for the innovation program would have to be “truly pioneering” and capable of “revolutionizing patient care or healthcare delivery” to be eligible. Those tapped would receive roadmap and timeline from the CDRH for the development, testing and review of the device. An FDA “case manager” would be assigned to each project, to help identify and address “important scientific issues” early on. The projects could also qualify for “flexible” clinical trial protocols, according to the agency.

The proposal is aimed at halving the time it takes for “high-risk or novel products” to win pre-market approval, with a target of 150 days.

The CDRH on released a white paper outlining its steps for the innovation initiative along with the announcement. A public hearing on the initiative is scheduled for March 15 in White Oak, Md.

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