Stuart Cain’s 4th Video on Metal on Metal Hip Damage & Suffering
Stuart Cain‘s 4th Video on metal on metal hip damage. Welcome to number 4 in our series of videos about …
Category Archives: 510k process
Her Third Set of Hips after Stryker Orthopedics Rejuvenate Modular Hip System Recall
#NA0103-001 / gettyimages.com Extract from Original article here: Her Third Set of Hips after Stryker Orthopedics Rejuvenate Modular Hip System Recall. …
Good News in the Preemption Battle – Claims Not Preempted
Full Article Link: DePuy Total Hip System Lawsuit – Claims Not Preempted. Federal Judge Refuses to Dismiss DePuy Total Hip System …
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’ …
DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable
Trial plaintiff says J&J hips defective, company says not liable. Trial plaintiff says J&J hips defective, company says not liable …
DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
DePuy Trial Continues Despite Talks of Settlement – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. DePuy Trial Continues …
When Doctors Keep Quiet about Dangerous Hip Devices
A doctor’s note to Johnson & Johnson (J&J) executives criticizing their marketing of a dangerous metal hip device was one …
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. …
26% Failure in Female Smith & Nephew BHR’s – The ten-year survival of the Birmingham… [J Bone Joint Surg Br. 2012] – PubMed – NCBI
26% Failure in Female Smith & Nephew BHR’s – and higher failure in older males… The ten-year survival of the …
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 Executives Knew About Plan to Spy on Whistle-Blower Scientists
FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists. FDA Executives Knew About Plan to Spy on Scientists August …
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 …
Lee’s post Smith & Nephew BHR Problems Continue….
I am 12 weeks post-op today (July 27 2012), following revision surgery of a BHR I received in Dec 2003, …
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 …
Anthony’s BHR hell. Just like DePuy. Come on Mr Smith & your Nephew – own up.
i had a bhr in 2003,after complaining about swelling and cicking in my hip i was told it was scar …
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 …
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 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 …
Smith & Nephew – Class 2 Recall R3 Constrained Acetabular Liner
Medical & Radiation Emitting Device Recalls. Class 2 Recall R3 Constrained Acetabular Liner Date Posted October 18, 2010 Recall Number …
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 Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …
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 …
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1
June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …
METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY
CTAF ASSESSMENT – METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY http://www.google.com.au/url?sa=t&rct=j&q=&esrc=s&source=web&cd=42&ved=0CFIQFjABOCg&url=http%3A%2F%2Fwww.ctaf.org%2Ffiles%2F769_file_Hip_resurfacing_W.pdf&ei=Ovr4T5bGI-yUiAfA5tzhBg&usg=AFQjCNGpF8andIjM3eQZ9JGMI58FwHyo7w&sig2=IPuN6AUkPw1Tt6yzEYt32Q. Or download the …
Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty
Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for …
Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems
Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM310217.pdf. This is a PDF …
FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel Gaithersburg Hilton, Gaithersburg, Maryland
FDA Executive Summary Memorandum Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices …
SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies
SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309356.pdf. Download PDF …
Smith & Nephew BHR – Food and Drug Administration, HHS
http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …
SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf
Source: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4181b1_03_SSED_BHR_080505.pdf. SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEM …
Attachment B – Ragab AA., validity of Self-Assessment Outcome Questionnaires: Patient-Physician Discrepancy in Outcome Interpretation, 39 Biomed. Sci. Instrum. 579-84 (2003)
http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-cp00001-03-Attachment-B-vol1.pdf. Biomed Sci Instrum. 2003;39:579-84. Validity of self-assessment outcome questionnaires: patient-physician discrepancy in outcome interpretation. Ragab AA. Department of Orthopedics, …
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, …
Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR
Dockets:. Dockets Management Back 2005P-0440 CP 1 Volume 1 Citizen Petition Attachment A – FDA, Summary Minutes, Meeting of the Orthopedic …
FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…
FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr. Roberts: Food and Drug …
Dockets: 2005P-0440: To deny approval of Smith & Nephew’s premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
Dockets: 2005P-0440: To deny approval of Smith & Nephew’s premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) …
Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA
Wright Medical’s Response to Smith & Nephew‘s Response to WMT request to Deny BHR PMA http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …
Premarket Approval (PMA) Database – BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …
P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices
P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices. PMA Application: P040033 S017 (Most recently approved supplement) Attribute …
Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL
Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL Post-Approval Studies. Post-Approval Studies FDA Home Medical Devices Databases – …
Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS????
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm127516.pdf. Hip Prostheses The Birmingham Hip Resurfacing (BHR) System, P040033, by Smith & Nephew Orthopaedics was approved on May 9, …
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 …
Defective DePuy Hips: The Empire (Johnson & Johnson) Strikes Back :: Accident and Injury Lawyer Blog
Defective DePuy Hips: The Empire (Johnson & Johnson) Strikes Back :: Accident and Injury Lawyer Blog. May 10, 2012, by …
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …
Gynecare Prolift Mesh Sold by J&J Without FDA Approval | InjuryBoard Fort Worth
Gynecare Prolift Mesh Sold by J&J Without FDA Approval | InjuryBoard Fort Worth. Gynecare Prolift Mesh Sold by J&J Without …
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 …
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 …
Stuart on DePuy ASR Disaster – “The question that I didn’t want to answer”
“The question that I didn’t want to answer” Late last year (2011), I was sitting on my back deck at …
Anon. replies to Katie’s Smith & Nephew BHR torment…
Hi Katie, I too am living in BHR MOM hell at present, and I am awaiting results on trace metal …
John’s Story – More Smith & Nephew BHR Misery @ 39 years old
John’s Story I had a Smith and Nephew Birmingham Hip Resurfacing in 2009 at age 39. It was presented to …
Katie’s Full Story – Metal on Metal BHR Mess
Hello Earl The following is an account of my personal experience with osteoarthritis, our healthcare system, and the Birmingham Hip …
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 …
FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline
Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …
Financial toll soars for hip implant failures – KansasCity.com
Financial toll soars for hip implant failures – KansasCity.com. Financial toll soars for hip implant failures By BARRY MEIER The …
JBJS | A Multinational Assessment of Metal-on-Metal Bearings in Hip Replacement
JBJS | A Multinational Assessment of Metal-on-Metal Bearings in Hip Replacement. There is emerging evidence that many metal-on-metal (MoM) bearings, …
The regulatory standards for the approval of medical devices in Australia – Senate Inquiry
The regulatory standards for the approval of medical devices in Australia – Senate Inquiry On 16 June 2011 the Senate …
Recalled DePuy ASR Hip Implant Lawsuits Filed By The Law Offices Of John David Hart – TheStreet
Recalled DePuy ASR Hip Implant Lawsuits Filed By The Law Offices Of John David Hart – TheStreet. Recalled DePuy ASR …
Zimmer Hip Lawyer | Zimmer Hip Implant Lawsuit News
Zimmer Hip Lawyer | Zimmer Hip Implant Lawsuit News. Pennsylvania Judge Dismisses Claims in Zimmer Hip Implant Lawsuit Shay Morrigan …
New Models of Hip and Knee Implants Not Better, Study Finds – NYTimes.com
New Models of Hip and Knee Implants Not Better, Study Finds – NYTimes.com. New Models of Implants Not Better, Study …
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 …
Bill Would Require More Monitoring of Implants – NYTimes.com
Bill Would Require More Monitoring of Implants – NYTimes.com. Bill Would Require More Monitoring of Implants By BARRY MEIER Published: …
San Francisco Personal Injury Attorney Analyzes Depuy Lawsuits And Preemption
San Francisco Personal Injury Attorney Analyzes DePuy Lawsuits And Preemption. DePuy Hip Implant Claims & Federal Preemption November 23, 2011 …
Pardon my skepticism…DePuy being Promoted by Actress who has had bilateral hip replacement
My View: Isn’t J&J DePuy involved in the biggest legal debacle this side of the orthopaedic boondocks – ASR, Pinnacle …
The Next Medical Device Controversy: Vaginal Mesh
Lawsuits against companies such as Johnson & Johnson are increasing as problems with the implants arise By David Voreacos and …
Metal Hips Failing Fast, Report Says – Of those patients in the British group who received the device six years ago, about 29 percent have since had it replaced.
Metal Hips Failing Fast, Report Says By BARRY MEIER Published: September 15, 2011 New York Times In a troubling development …
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 …
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 Australian – Medical devices in spotlight
Medical devices in spotlight Sue Dunlevy From: The Australian August 27, 2011 12:00AM Bob Lugton, on his boat outside his home …
Groundswell of Grievances Against Manufacturers of Defective, Dangerous Hip Replacement Devices
Rottenstein Law Group Heeds Groundswell of Grievances Against Manufacturers of Defective, Dangerous Hip Replacement Devices NEW YORK, Aug. 24, 2011 …
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 …
Reuters-INSIGHT-DePuy’s handling of hip recall sparks questions
Reuters-INSIGHT-DePuy’s handling of hip recall sparks questions By Toni Clarke; Tue, Aug 2 2011; Mon Aug 22, 2011 6:45am EDT …
U.S. government examining doctor kickbacks for medical devices
U.S. government examining doctor kickbacks for medical devices By Barnaby J. Feder Published: Monday, March 24, 2008 NY Times NEW …
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 …
Medical Devices — Balancing Regulation and Innovation
Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …
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 …
British Woman files product liability lawsuit against Wright Medical Technology
Wright Hip Replacement Lawsuit Filed by Woman from Great Britain Source: AboutlawSuites.com Published: July 29th, 2011 An U.K. woman has …
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 …
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 …
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; …
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 …
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 …
Earl's View 