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
International Medical Device Regulatory Update: News and Views From San Jose
By Randolph Fillmore -
Published 20 December 2016
Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.
Categories: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration
Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS
FDA Commissioner Calls for Better National System to Track Device Safety
By Zachary Brennan -
Published 11 July 2016
The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA.
Categories: News, US, CDRH, Medical Devices, Postmarket surveillance
Tags: Sentinel, device safety, NEST, GAO, Robert Califf