Search Results for Shuren

Showing 1 – 25  of 29

Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says By Zachary Brennan - Published 09 January 2018

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: parallel review, Shuren, MOU

Building NEST: New Executive Director, CDRH's Shuren Discuss Plans By Zachary Brennan - Published 27 September 2017

The group of stakeholders building the National Evaluation System for health Technology (NEST) outlined what’s in store for the new future as well as the direction that they want the system to go.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: NEST, real world data, Jeff Shuren

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition By Alexander Gaffney, RAC - Published 03 September 2014

Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups, including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Research and development, Submission and registration

Tags: LDT, Lab-Developed Tests, Laboratory-Developed Tests, 21st Century Cures Initiative, Congress, House, CDRH, Jeffery Shuren

CDRH Whistleblowing Scandal Back in Spotlight as Congress Again Takes Interest By Alexander Gaffney, RAC - Published 25 February 2014

Categories: US, FDA, CDRH

Tags: House Oversight Committee, FDA Nine, Charles Grassley, Whistleblower, House, Jeffery Shuren

Mobile App Regulation Focus of Upcoming Legislative Hearing By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: SOFTWARE Act, Mobile Health App, Mobile App, Latest News, Jeffery Shuren, medical device

House Legislators Set to Grill FDA on FDASIA Progress By Alexander Gaffney, RF News Editor - Published 13 November 2013

Categories: US, FDA

Tags: FDASIA, Energy and Commerce Committee, Hearing, House, Janet Woodcock, Latest News, Jeffery Shuren

Shuren: CDRH Actively Assessing 3D Printing, Expect Guidance Within Next Two Years By Alexander Gaffney, RF News Editor - Published 26 September 2013

Categories: US, FDA

Tags: Jeffery Shuren

Hamburg, Shuren Say CDRH Set to Meet MDUFA Goals This Year By Alexander Gaffney, RF News Editor - Published 26 September 2013

Categories: US, FDA

Tags: Jeffery Shuren

FDA Data Show the Worst is Over for 510(k), PMA Submissions By Alexander Gaffney, RF News Editor - Published 17 May 2013

Categories: US, FDA

Tags: Jeffery Shuren, 510(k), PMA

Reporting Adverse Events? There's an App for That, But Not for Industry--Yet By Alexander Gaffney, RF News Editor - Published 24 April 2013

Categories: US, FDA, CDRH

Tags: William Maisel, Jeffery Shuren

CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion By Alexander Gaffney, RF News Editor - Published 05 December 2012

Categories: Reports, FDA, CDRH

Tags: Strategic Plan, 2013, Shuren, Latest News, plan, staff, guidance, medical device

Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA By Alexander Gaffney - Published 02 October 2012

Categories: FDA, CDRH

Tags: Kohn, NWC, National Whistleblowers Council, Reviewers, Whistleblowers, Taylor, FDA Nine, Shuren, Lawsuit, Latest News, medical device

Legislators Call for Publicly Available 510(k) Database to Address 'Loophole' By Alexander Gaffney - Published 20 August 2012

Categories: FDA, CDRH

Tags: Legislators, Loophole, Merkley, Shuren, Markey, House, Latest News, 510(k), medical device

Report: Monitoring Scandal Involves Top FDA Officials By Alexander Gaffney - Published 07 August 2012

Categories: FDA

Tags: FDA 9, Surveillance, FDA Nine, Shuren, Monitoring, Latest News, Hamburg

Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices By Alexander Gaffney - Published 16 July 2012

Categories: FDA, CDRH

Tags: Kohn, NWC, National Whistleblowers Council, Reviewers, Whistleblowers, Taylor, FDA Nine, Shuren, Lawsuit, Latest News, medical device

Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective By Alexander Gaffney - Published 23 April 2012

Categories: Europe, EMA, FDA, CDRH, Medical Devices

Tags: Criticism, Criticize, Maisel, Shuren, Report, Latest News, safety, EU, medical device

Drafts of PDUFA, MDUFA Released in House, Senate By Alexander Gaffney - Published 19 April 2012

Categories: FDA

Tags: Vote, Discussion Draft, HELP Committee, Energy and Commerce Committee, Shuren, Woodcock, User Fees, Legislation, House, MDUFA, Latest News, Senate, Congress, PDUFA

FDA Opens Innovation Pathway to First Round of Devices By Alexander Gaffney - Published 10 April 2012

Categories: CDRH

Tags: End Stage Renal Disease, Kidney, ESRD, Shuren, Innovation Pathway, Latest News, medical device

Shuren's Senate Testimony Yields Wealth of Insight By Alexander Gaffney - Published 30 March 2012

Categories: FDA, CDRH

Tags: Testimony, Shuren, Reauthorization, MDUFA, 2012, Latest News, Congress, medical device

Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA By Alexander Gaffney - Published 28 March 2012

Categories: FDA, CDER, CDRH

Tags: BIO, Pew, Testimony, Shuren, GPhA, Woodcock, PhRMA, AdvaMed, Latest News, HELP, Congress, committee

Shuren: Predicate Device 'Loophole' Must Be Closed By Alexander Gaffney - Published 28 February 2012

Categories: FDA, CDRH

Tags: Substantially Equivalent, Predicate, HR 3847, Shuren, Sound Devices Act, Latest News, Jeffery Shuren, 510(k), safety, medical device

Hoping to Relax Regulatory Burdens, Medical Device Manufacturers Gain Clout on the Hill By Alexander Gaffney - Published 27 February 2012

Categories: FDA, CDRH

Tags: Clout, Influence, Shuren, IOM, AdvaMed, Latest News, Bill, Congress, Political

MDUFA Hearing Tomorrow, FDA's Shuren to Testify By Alexander Gaffney - Published 14 February 2012

Categories: FDA, CDRH

Tags: Energy and Commerce Committee, Shuren, Hearing, MDUFA, Latest News, Congress

Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns By Alexander Gaffney - Published 30 January 2012

Categories: FDA, CDRH, Medical Devices

Tags: Charles Grassley, Concerns, Whistleblower, Effectiveness, HHS, Latest News, Jeffery Shuren, DHHS, Congress, safety