FDA Plans to Speed Up Approvals for Medical Technology

posted on Feb 16 by Snow in the Disability News, Health, Healthcare, Technology, Wheelchair Technology category

According to the FDA’s website, a priority review program for new, breakthrough medical devices is part of a broader effort underway in the FDA’s Center for Devices and Radiological Health (CDRH), designed to encourage  new technologies among medical device manufacturers. The newly proposed “Innovation Pathway” states that products have to be “pioneering technologies with the potential of revolutionizing patient care or health care delivery”. Those products that get selected would receive an Innovation Pathway memorandum from CDRH containing a time line for device development, and the product would then be assigned a case manager.

The FDA has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) which is a brain-controlled, upper-extremity prosthetic designed to restore near natural arm functionality with the hand and fingers. This arm can be used for patients who have suffered from spinal cord injury, stroke, or amputation. The arm uses a microchip implanted on the surface of the brain and decodes signals to control it. DARPA and the FDA have signed a Memorandum of addressing both the development and review of this project.

Why has CDRH launched the Medical Device Innovation Initiative? According to their website, facilitating innovation is a top priority for CDRH and they recognize that transformative, innovative devices can present new scientific and regulatory challenges.  The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product’s timely progress to market. The Medical Device Innovation Initiative is part of CDRH’s 2011 Strategic Priorities.  CDRH will hold a public meeting on March 15, 2011, and will continue to solicit feedback on the Innovation Initiative through a public docket until May 31, 2011.