The FDA is holding a public meeting today on the “Innovation Initiative” it announced last month, which is aimed at fostering breakthrough medical technologies.
The federal watchdog agency also said it will convene a workshop today in Silver Spring, Md., on how to create a database of medical device labeling and pictures without revealing any device makers’ proprietary information.
Watch a video of CDRH head Dr. Jeffrey Shuren explaining the Innovation Initiative
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.
The new regulatory pathway, which is slated to undergo public review before more projects are selected, is the Center for Devices & Radiological Health’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 at the time. “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 also said it will hold a public meeting on the creation of public databases of medical device labels and product photographs. The aim is a repository of data for the public, researchers and the medical device industry.
“There might also be a photo of the device and any acceptable accessories,” according to a press release. “We anticipate that the repository would not include service and technical manuals, nor would it supply any proprietary information.”
The meeting is slated for April 7 in Silver Spring, Md.