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Tag Archives: Center for Devices and Radiological Health

FDA Aims To Smooth Premarket Review process | Bloomberg BNA

August 24, 2012

FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …

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Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes

August 18, 2012

Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …

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FDA to help medical device sales with expanded pre-market feedback program

July 15, 2012

FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …

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Smith & Nephew BHR FDA-required Post-Approval Studies

July 15, 2012

Smith & Nephew BHR FDA-required Post-Approval Studies Post-Approval Studies In January 2005, the oversight responsibility of the Post-Approval Studies Program …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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FDA to guide device makers on marketing application – chicagotribune.com

July 14, 2012

FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …

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FDA – User Fees for Medical Devices: Third Time Lucky?

July 8, 2012

User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …

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Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today

July 8, 2012

Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …

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New FDA guidance on considerations used in device approval

July 7, 2012

New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …

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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

January 7, 2012

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …

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FDA seeks to include more women in medical device trials

December 20, 2011

FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …

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Vaginal / Pelvic Mesh lawsuits pile up for C.R. Bard

October 2, 2011

Mesh lawsuits pile up for C.R. Bard September 29, 2011 by MassDevice staff Lawsuits accusing C.R. Bard of selling defective …

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J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies

September 14, 2011

J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies September 08, 2011, 4:42 PM EDT Source: Bloomberg By Alex …

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LegalView Announces New Vaginal Mesh Litigation Portal

August 30, 2011

LegalView Announces New Vaginal Mesh Litigation Portal LegalView, an online legal resource, will ow offer free legal case evaluations regarding …

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FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices

August 20, 2011

FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011  Source: Medical Design Online For the first …

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FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

August 15, 2011

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …

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FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units

August 13, 2011

Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …

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FDA Seeks Public Views on Proposed 510(k) Plans

August 2, 2011

FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …

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Report: FDA’s Medical Device Approval Process Is Flawed

July 31, 2011

Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …

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Expert group calls for new way to clear medical devices

July 31, 2011

Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …

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Advisory panel calls for revamping FDA approval process for medical devices

July 31, 2011

Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …

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FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report

July 31, 2011

FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …

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Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process

July 31, 2011

Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …

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Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs

July 30, 2011

Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …

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FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process

July 30, 2011

Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …

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510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release

July 30, 2011

510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …

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Report: IOM review of the FDA 510(k) process due Friday

July 28, 2011

Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …

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Is Medical Device Design Going to the Dogs?

July 17, 2011

Is Medical Device Design Going to the Dogs? Published: May 23, 2011 The Massachusetts-based Worcester Business Journal featured an interesting …

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Senate Hearing on FDA Medical Device Approvals

July 10, 2011

DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …

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Corin 510K Approval Details

July 6, 2011

Corin FDA Approvals Source: click here Corin 510K Biolox FDA Approval K103120.pdf Corin Minhip K083312.pdf Corin BIOLOX delta Modular Femoral …

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