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’ …
Category Archives: FDA 510k process
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 …