The FDA today announced “Innovation Pathway”, a new program to speed through regulatory approvals for groundbreaking medical technology. The first test case in the process will be an unnamed DARPA prosthetic arm that is controlled via a brain-computer interface implanted on the surface of the patient’s brain.
A bit more about the arm from the FDA press release:
The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic 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. DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project.
Stated features of the Innovation Pathway project:
products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery; selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.