As of April 15, 2015, a year after its initial proposal, FDA will begin to accept applications to participate in its new accelerated review program. The program is intended for critical devices defined as, “devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.” FDA plans to increase access to resources including senior management and case managers in order to leapfrog the acceleration review process. Ultimately, this accelerated review program will provide an avenue for potential life-saving devices to reach those patients in need sooner.
To learn more, read FDA’s guidance here.