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Earl's View

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Earl's View

Category Archives: FDA 510k process

How does the FDA ‘approve’ medical products? – Medical News Today

February 22, 2014

Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …

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NEJM Article about 510(k) Ancestry Reveals Problems with Metal Hip Implants

January 30, 2013

The national law firm of Anapol Schwartz applauds New England Journal of Medicine’s (NEJM) recent article about serious flaws in …

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Cardiologist William Maisel (deputy director for science at the FDA) Arrested In Prostitution Sting Operation – Forbes

January 20, 2013

Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, Contributor I’m a medical journalist covering cardiology news. …

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F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants

January 17, 2013

F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants By BARRY MEIER Published: January 16, 2013 Source: New York Times …

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Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process

September 7, 2012

Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …

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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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FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List”

August 22, 2012

FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List,” Raise More Questions About the …

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Dems urge FDA to boost medtech recall database | MassDevice.com

August 19, 2012

Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …

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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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Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno

July 29, 2012

Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …

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FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers

July 29, 2012

FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …

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Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com

July 28, 2012

Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …

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What does the FDA have to Hide? Who do they work for??

July 28, 2012

FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …

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Smith and Nephew BHR: Mr. Smith, his nephew, and the incident involving their missing BHR Modular Head

July 26, 2012

I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …

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Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne

July 23, 2012

Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne. Troubled Hip Implants Require Additional Patient Monitoring JULY 20, …

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Is the US Medical Device Industry Heading the Way of the Dinosaur?

July 21, 2012

Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …

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Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register

July 21, 2012

Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …

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FDA surveillance operation draws criticism from lawmakers | Reuters

July 16, 2012

FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …

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POLICE STATE??? F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com

July 15, 2012

F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com. In Vast Effort, F.D.A. Spied on E-Mails of Its Own …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Medical Device ID Proposal Unveiled – GovInfoSecurity

July 15, 2012

Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …

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Hip implant materials swing sharply to polyethylene | PlasticsToday.com

July 15, 2012

Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …

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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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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 – 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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FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today

July 8, 2012

FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …

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MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

July 8, 2012

MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2

July 8, 2012

June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …

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FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, at 12 (Sept. 8, 2005)

July 8, 2012

FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …

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FDA Cuts a Deal to Fast Track Drugs and Devices

May 13, 2012

FDA Cuts a Deal to Fast Track Drugs and Devices. By MERRILL GOOZNER, The Fiscal Times May 11, 2012 Over the …

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Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune

May 12, 2012

Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune. Submitted by Nimisha Sachdev on Thu, 05/10/2012 …

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FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra

March 24, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …

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DePuy Exec’s seem to think money comes first – F.D.A. Asked DePuy for Safety Data Just Before Hip Implant’s Phaseout – NYTimes.com

March 24, 2012

F.D.A. Asked DePuy for Safety Data Just Before Hip Implant’s Phaseout – NYTimes.com. Hip Device Phaseout Followed F.D.A. Data Request …

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Metal-on-Metal Hips Need Work More Quickly

March 14, 2012

  By John Gever, Senior Editor, MedPage Today Published: March 12, 2012 Revision of total hip replacement surgery within five years …

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Consumer Reports taps ire over bad medical devices

March 14, 2012

(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …

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BBC News – Surgeons call for end to metal hip replacements

March 7, 2012

BBC News – Surgeons call for end to metal hip replacements. Surgeons call for end to metal hip replacements By …

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The Power of the Birmingham Hip Resurfacing – NOT

January 21, 2012

Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …

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China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch

January 7, 2012

China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch. Jan. 6, 2012, 7:31 a.m. EST China …

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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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Howards View on the FDA and Medical Device Failures

January 7, 2012

Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …

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Howard View – on a few things

December 30, 2011

Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …

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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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Howard Sdwin: What isn’t being published is the truth regarding the medical device world

December 17, 2011

What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …

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Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA

October 24, 2011

Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA The Rottenstein Law …

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US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients

October 7, 2011

US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients & Applauds NBC News For …

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Howard Sadwin’s Story – a lesson in perserverance…

September 17, 2011

Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …

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Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster

August 28, 2011

Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster Date Published: Wednesday, August 24th, 2011 Source; News Inferno …

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The rate at which FDA issues 483s and warning letters is going up, up, up.

August 25, 2011

The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …

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Complaints Surge About Crumbling Artificial Hips

August 24, 2011

Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …

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INSIGHT – DePuy’s handling of hip recall sparks questions =2

August 23, 2011

INSIGHT – DePuy‘s handling of hip recall sparks questions =2 22 Aug 2011 12:21 Source: reuters // Reuters METAL POISONING …

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