FDA Launches Expedited Device Approval Program Without Including 510(k)s

FDA will begin accepting applications from industry next Wednesday (April 15) to participate in a major new program to expedite approval of medical devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases, but the final program design unveiled April 8 is limited to premarket approval and de novo devices, rejecting industry's call for inclusion of 510(k)s. This comes as House lawmakers push a broader device priority review program that includes 510(k)s as part of their 21st Century...