The proposed Innovation Pathway program is part of a broader effort by the FDA’s Center for Devices and Radiological Health to encourage research and development of cutting-edge technologies among manufacturers.
Proposed actions for the program include establishing a certification program for medical device test centers, creating a core curriculum for medical device development and testing and using more device experience and data collected outside the U.S.
A brain-controlled, upper-extremity prosthetic will serve as the pilot for the program.
Read the news release about Innovation Pathway.
Read other coverage about medical devices:
– Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices
– Medical Device Market to Present Greater Opportunity, Greater Challenges to Companies
– New Device Manufacturer Tax Could Increase Medical Device Outsourcing
