Breakthrough Devices: FDA Issues Draft Guidance
By Michael Mezher -
Published 24 October 2017
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance detailing the agency's new program for breakthrough medical devices created by the 21st Century Cures Act.
Categories: News, US, FDA, Medical Devices, Regulatory strategy, Submission and registration
Tags: Breakthrough Devices Program, Priority Review
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
CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices
By Zachary Brennan -
Published 31 May 2016
A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program.
Categories: News, US, CDRH, Clinical, Government affairs, Medical Devices, Postmarket surveillance
Tags: expedited device approvals, EAP, breakthrough devices
Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices
By Alexander Gaffney, RAC -
Published 27 April 2015
Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.
Categories: News, US, CDRH, Medical Devices
Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill