The FDA notoriously takes forever to approve new drugs and medical procedures, all in the name of so-called “safety” and “preventing flipper-babies.” But they’re hoping to reverse that image by unveiling a new “Innovation Pathway” program that will cut down the approval process by half for new technologies. The system would require that:
- “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.”
So, there’s clearly several approval hurdles for a new piece of tech to get through before it can get into the quick approval program. The first piece of technology in the pipeline? A DARPA-developed mind-controlled robot arm. As the FDA press release says:
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.
Whatever bureaucratic flaws the process may have, at least they’re starting off with a military-funded robotic power arm that’s wired into your brain. After all, what could go wrong with that?