CDRH Plots Path to New 'Progressive' Approvals for Some Devices
By Zachary Brennan -
Published 03 May 2017
With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.
Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy
Tags: NEST, MDUFA IV, progressive approvals, breakthrough devices