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 …
Tag Archives: Institute of Medicine
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 …
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 …
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 …
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 …
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 …
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 …
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) …
Australian TGA – Reforms in the medical devices regulatory framework: Overview of submissions
Reforms in the medical devices regulatory framework: Overview of submissions 11 February 2011 Background On 2 November 2010, the TGA released a …
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 …
US Congress Women Rosa L. DeLauro Takes FDA To Task Over Comments re IOM Report
For Immediate Release Friday, July 29, 2011 Contact: Kaelan Richards 202-225-3661 DELAURO TO FDA: 510(k) MEDICAL DEVICE APPROVAL PROCESS UNSAFE, …
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 …
U.S. advisers call for new medical device regime
U.S. advisers call for new medical device regime Andrew Seaman Reuters Full Edition July 30, 2011 WASHINGTON (Reuters) – An …
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 …
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 …
Advisory panel calls for revamping FDA approval process for medical devices
Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …
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 …
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 …
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) – …
Barry Meier – Study Faults Approval Process for Medical Devices
Study Faults Approval Process for Medical Devices BY BARRY MEIER PUBLISHED: JULY 29, 2011 NEW YORK TIMES The government’s system for regulating …
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 …
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 …
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 …
New Study Shows That Pain Costs Billions of Dollars a Year in U.S.
100 Million Americans Have Chronic Pain New Study Shows That Pain Costs Billions of Dollars a Year in U.S. By …
Corin Cormet Presentation to FDA Approvals Panel
Corin Presentation to FDA Approvals Panel Ever wonder what they tell the panel to get a 510K approval… Download presentation …
Corin 510K Approval Details
Corin FDA Approvals Source: click here Corin 510K Biolox FDA Approval K103120.pdf Corin Minhip K083312.pdf Corin BIOLOX delta Modular Femoral …
Sadwin Gives them a Sterling Suggestion or Two
Just in from Howard’s Desk (wheel chair) … I just sent a feedback message to med page. How ridiculous it …