Tag Archives: medical devices

FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration (FDA) and the Brookings Center for Health Policy, the Planning … Continue reading this entry

FDA Announces Plan for Expedited Review of Certain Medical Devices

The Food and Drug Administration (FDA) published proposed guidance on April 22nd for a voluntary expedited access program for new high-risk medical devices that are intended to treat or diagnose patients with serious conditions that are unaddressed by approved technology. The guidance, titled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need … Continue reading this entry