Search Results for breakthrough devices

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Breakthrough Devices: FDA Issues Draft Guidance By Michael Mezher - Published 24 October 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance detailing the agency's new program for breakthrough medical devices created by the 21st Century Cures Act.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