FDA Aims To Smooth Premarket Review process | Bloomberg BNA
FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …
Tag Archives: Center for Devices and Radiological Health
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …
FDA to help medical device sales with expanded pre-market feedback program
FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …
Smith & Nephew BHR FDA-required Post-Approval Studies
Smith & Nephew BHR FDA-required Post-Approval Studies Post-Approval Studies In January 2005, the oversight responsibility of the Post-Approval Studies Program …
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …
FDA to guide device makers on marketing application – chicagotribune.com
FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …
FDA – User Fees for Medical Devices: Third Time Lucky?
User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …
New FDA guidance on considerations used in device approval
New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …
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
Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …
FDA seeks to include more women in medical device trials
FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …
Vaginal / Pelvic Mesh lawsuits pile up for C.R. Bard
Mesh lawsuits pile up for C.R. Bard September 29, 2011 by MassDevice staff Lawsuits accusing C.R. Bard of selling defective …
J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies
J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies September 08, 2011, 4:42 PM EDT Source: Bloomberg By Alex …
LegalView Announces New Vaginal Mesh Litigation Portal
LegalView Announces New Vaginal Mesh Litigation Portal LegalView, an online legal resource, will ow offer free legal case evaluations regarding …
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011 Source: Medical Design Online For the first …
FDA Loosens Premarket Notification Requirements for 30 Medical Device Types
FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …
FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units
Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …
FDA Seeks Public Views on Proposed 510(k) Plans
FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …
Report: FDA’s Medical Device Approval Process Is Flawed
Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …
Expert group calls for new way to clear medical devices
Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …
Advisory panel calls for revamping FDA approval process for medical devices
Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …
Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process
Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …
Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs
Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …
FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process
Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …
Report: IOM review of the FDA 510(k) process due Friday
Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …
Is Medical Device Design Going to the Dogs?
Is Medical Device Design Going to the Dogs? Published: May 23, 2011 The Massachusetts-based Worcester Business Journal featured an interesting …
Senate Hearing on FDA Medical Device Approvals
DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …
Corin 510K Approval Details
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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