The FDA has proposed a new set of guidelines that would help speed approval of groundbreaking new devices as well as foster device innovation. The move is part of a broader effort to encourage game-changing technologies among medical device manufacturers.
In the new system, the agency will identify transformative technologies and assign an FDA case manager to assist the company through the regulatory process. The companies will also receive a roadmap and timeline for device development, clinical assessment and regulatory review. Case managers will help companies address important scientific issues early in the development process. In a statement, FDA device head Jeffrey Shuren said the new program "will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health need." He admitted, however, that at first only one or two companies a year would qualify for the pathway.
The first device recognized by the new program is a super-dexterous robotic arm operated by a chip that decodes signals from the brain. The Pentagon spent five years $100 million developing the technology, according to the LA Times, and hopes to initially test it in service members who've lost limbs in combat. Eventually the robotic arm could be used to help replace limbs lost as a result of spinal cord injury, stroke or amputation.
- see the FDA announcement
- here's the Reuters report
- read more from the LA Times