Can Your Hip Replacement Kill You?
NY Times By JEANNE LENZERJAN. 13, 2018 When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to …
Category Archives: FDA 510k process
How does the FDA ‘approve’ medical products? – Medical News Today
Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …
NEJM Article about 510(k) Ancestry Reveals Problems with Metal Hip Implants
The national law firm of Anapol Schwartz applauds New England Journal of Medicine’s (NEJM) recent article about serious flaws in …
Cardiologist William Maisel (deputy director for science at the FDA) Arrested In Prostitution Sting Operation – Forbes
Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, Contributor I’m a medical journalist covering cardiology news. …
F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants
F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants By BARRY MEIER Published: January 16, 2013 Source: New York Times …
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …
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 …
FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List”
FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List,” Raise More Questions About the …
Dems urge FDA to boost medtech recall database | MassDevice.com
Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …
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 …
Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno
Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …
FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers
FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …
Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com
Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …
What does the FDA have to Hide? Who do they work for??
FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …
Smith and Nephew BHR: Mr. Smith, his nephew, and the incident involving their missing BHR Modular Head
I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …
Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne
Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne. Troubled Hip Implants Require Additional Patient Monitoring JULY 20, …
Is the US Medical Device Industry Heading the Way of the Dinosaur?
Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …
FDA surveillance operation draws criticism from lawmakers | Reuters
FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …
POLICE STATE??? F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com
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 …
FDA – Overview of Medical Device Regulation > Information about MDUFA III
Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …
Medical Device ID Proposal Unveiled – GovInfoSecurity
Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …
Hip implant materials swing sharply to polyethylene | PlasticsToday.com
Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …
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 …
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 – 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, …
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2
June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …
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)
FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …
FDA Cuts a Deal to Fast Track Drugs and Devices
FDA Cuts a Deal to Fast Track Drugs and Devices. By MERRILL GOOZNER, The Fiscal Times May 11, 2012 Over the …
Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune
Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune. Submitted by Nimisha Sachdev on Thu, 05/10/2012 …
FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra
FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …
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
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 …
Metal-on-Metal Hips Need Work More Quickly
By John Gever, Senior Editor, MedPage Today Published: March 12, 2012 Revision of total hip replacement surgery within five years …
Consumer Reports taps ire over bad medical devices
(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …
BBC News – Surgeons call for end to metal hip replacements
BBC News – Surgeons call for end to metal hip replacements. Surgeons call for end to metal hip replacements By …
The Power of the Birmingham Hip Resurfacing – NOT
Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …
China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch
China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch. Jan. 6, 2012, 7:31 a.m. EST China …
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 …
Howards View on the FDA and Medical Device Failures
Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …
Howard View – on a few things
Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …
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 …
Howard Sdwin: What isn’t being published is the truth regarding the medical device world
What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …
Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA
Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA The Rottenstein Law …
US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients
US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients & Applauds NBC News For …
Howard Sadwin’s Story – a lesson in perserverance…
Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …
Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster
Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster Date Published: Wednesday, August 24th, 2011 Source; News Inferno …
The rate at which FDA issues 483s and warning letters is going up, up, up.
The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …
Complaints Surge About Crumbling Artificial Hips
Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …
INSIGHT – DePuy’s handling of hip recall sparks questions =2
INSIGHT – DePuy‘s handling of hip recall sparks questions =2 22 Aug 2011 12:21 Source: reuters // Reuters METAL POISONING …
Hip Implant Complaints Surge, Even as the Dangers Are Studied
Hip Implant Complaints Surge, Even as the Dangers Are Studied By BARRY MEIER and JANET ROBERTS Source: The New York …
Orthopedic companies settle DOJ probe, face SEC scrutiny; Medtronic loses a patent suit to Johnson & Johnson, releases new spinal device
Orthopedic companies settle DOJ probe, face SEC scrutiny; Medtronic loses a patent suit to Johnson & Johnson, releases new spinal …
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 …
IOM chair discusses 510(k) report: origins, findings, response
IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham August 15, 2011 Source: Cardiovascular Business David …
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 …
Sadwin gets to the heart of the Issues with FDA 510(k)
Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …
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 …
Medical Devices — Balancing Regulation and Innovation
Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …
IOM Gives FDA The wrong prescription on medical devices & 510(k)
Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …
Hips and Hip Replacements: What you need to know
Hips and Hip Replacements: What you need to know by Thomas W. Miller Ph.D. ABPP, Staff Writer Published Online Aug …
How Safe Are Medical Devices?
How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …
How ‘Bout Smith & Nephew
How ‘Bout Smith & Nephew posted by Karen on 02 Aug 2011 at 6:34 pm All this data refers to …
Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants?
Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …
New Chromium and Cobalt Test to Assist the Medical Community
August 03, 2011 10:07 AM Eastern Daylight Time NMS Labs Announces Its New Chromium and Cobalt Test to Assist the Medical …
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) …
South Australia – DePuy Hip implant class action grows
Hip implant class action grows David Jean From The Advertiser August 01, 2011 12:00AM An orthopedic surgeon studies a patient’s …
Australian TGA – Reforms in the medical devices regulatory framework
Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …
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 …
510(k) approval process is too big to fail no matter how flawed it may be
7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …
Barry Meier – Approval process for devices blasted
Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The government’s system for regulating many medical …
Sadwin Comments on Washington Post Article – Letter to Authors
Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …
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 …
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 …
Report could sway FDA device review process
Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …
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 …
Barry Meier – Study of Medical Device Rules Is Attacked, Unseen
Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …
Why Are Pharmaceutical Companies Paying The FDA?
Why Are Pharmaceutical Companies Paying The FDA? Posted by Amber Racine J uly 27, 2011 10:31 AM Source: Click here The FDA …
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 …
History – Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip
Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip June 25, 2006 By: Victor Rocha Website: http://www.hip-replacement-care.com Smith & …
FDA medical device review times to be subject of House hearing
FDA medical device review times to be subject of House hearing The House Energy & Commerce Committee’s oversight subcommittee is …
Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed
Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed [Targeted News Service] WASHINGTON, May 24 — The …
Sadwin Asks the Hard Questions of the Hip Replacement Companies
I had the privilege of getting some great questions from Howard last night and I thought that they, along with …
First DePuy ASR Hip Implant Lawsuit Hearing Convened
First DePuy ASR Hip Implant Lawsuit Hearing Convened Date Published: Wednesday, January 26th, 2011 The first hearing for federal DePuy …
What the FDA has to say About Metal on Metal Hips
What the FDA has to say About Metal on Metal Hips FDA Website – click here Metal-on-Metal Hip Implants Hip …
FDA Metal-on-Metal Hip Implant Website Details Risks
FDA Metal-on-Metal Hip Implant Website Details Risks Date Published: Friday, February 18th, 2011 The U.S. Food & Drug Administration (FDA) …
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, …
FDA 510K Process for Medical Devices Let Unsafe Devices Through
FDA Again Criticized for Medical Device Oversight Date Published: Wednesday, April 13th, 2011 Thousands of medical devices are approved annually …
Earl's View 