FDA outlines fast-track plan to speed development of innovative devices
The agency's Innovation Pathway program, which echoes the National Institutes of Health's drug development initiative announced last month, will feature as its pilot candidate a brain-controlled prosthetic arm that would allow amputees “almost lifelike movement,” including a thumb.
The arm was developed by the Defense Advanced Research Projects Agency (DARPA) to treat battlefield injuries. It uses a microchip implanted on the surface of the brain to translate neural activity into movement. It fits the parameters of the Innovation Pathway program, which calls for “truly pioneering technologies with the potential of revolutionizing patient care.”
Experimental devices included in the program, to be run through the Center for Devices and Radiological Health, would receive a proposed roadmap and timeline for device development, clinical assessment and regulatory review, and would be assigned a case manager. Key scientific issues could be identified earlier in the process, the agency said, and candidates could qualify for flexible clinical trial protocols. Premarket reviews of products in the Pathway would take no more than 150 days – nearly half the time it currently takes the agency to conduct normal reviews.
The agency will seek public input before further implementing the Pathway program, which would also:
- Establish a voluntary, third-party certification program for US medical device test centers aimed at promoting rapid improvements to technologies in the development and clinical testing phases;
- Create a publicly-available core curriculum for device development and testing to train the next generation of innovators
- Use more device experience and data collected outside the US
CDRH also plans to engage in “formal horizon scanning,” monitoring medical literature and scientific funding to determine where technology is heading.
It's the latest indication of the Obama administration's concern that the US is losing its edge in medical technology. In remarks announcing the program, FDA Commissioner Margaret Hamburg said she hoped the program would serve as a “catalyst for innovation.”
CDRH will host a public meeting on the Innovation Pathway initiative March 15 at its White Oak, MD campus.