Breaking Through FDA’s New “Accelerated” Pathway

For years, FDA’s Center for Device and Radiological Health (CDRH) has been criticized for stalling innovation due to long review times. In 2011, CDRH proposed the Innovation Pathway, a priority review program to help breakthrough medical devices reach patients in a timely manner by improving collaboration between FDA and manufacturers and shorten the time and reduce the costs from concept to commercialization for innovative medical devices.