FDA Launches Priority Review Program for Breakthrough Medical Products

Photograph courtesy of The Johns Hopkins University Applied Physics Laboratory (JHU/APL).

The U.S. Food and Drug Administration (FDA) has proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-limb prosthesis that will serve as a pilot for the program. The arm system, funded by the Defense Advanced Research Projects Agency (DARPA), is designed to restore near-natural arm, hand, and finger function to patients suffering from spinal cord injury, stroke, or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis.

The 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 proposes actions CDRH could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science. It will also seek to strengthen the nation's research infrastructure for developing breakthrough technologies and advancing quality regulatory science.

In addition, 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.

"Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions," said CDRH Director Jeffrey Shuren, MD, JD. "CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs."

Applications for the Innovation Pathway program would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprises senior managers and experienced scientists who would facilitate this device development and evaluation process. Enrollment in the program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.

Because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be approval pathways intended for either high-risk or novel products. The FDA could conduct 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.

The FDA has announced plans to seek further public comment before the Pathway can be used more broadly.

For more information, see the FDA press release regarding this initiative at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242629.htm