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 Warning
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 …
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: …
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 …
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 …
Johnson & Johnson hit with FDA warning letter | MassDevice – Medical Device Industry News
Johnson & Johnson hit with FDA warning letter | MassDevice – Medical Device Industry News. Johnson & Johnson hit with …
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 …
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 …
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 …
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. …
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 …
Recalled DePuy ASR Hip Implant Failure Leads to Lawsuit Filed by the Law Offices of John David Hart
Recalled DePuy ASR Hip Implant Failure Leads to Lawsuit Filed by the Law Offices of John David Hart Pecos, New …
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 …
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 …
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; …
‘Metal on metal’ hip implants leave some recipients in pain, at risk
‘Metal on metal’ hip implants leave some recipients in pain, at risk By Anita Creamer; The Sacramento Bee – click …
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 …
FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10
FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10 Department of Health and Human Services Public Health ServiceFood and Drug …