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The U.S. Food and Drug Administration is charged with ensuring the safety and effectiveness of medical devices in the United States...
What is a Medical Device?
   

     

The U.S. Food and Drug Administration is charged with ensuring the safety and effectiveness of medical devices in the United States...

GAO Report Suggests FDA Changes
A report issued on January 15, 2009 by the Government Accountability Office (GAO), the investigative arm of Congress responsible for enhancing the performance of all federal government agencies, concludes that the FDA has approved many medical devices that have never been shown to be safe or effective.
MP3 Headphones May Interfere with Implantable Devices
Headphones for portable digital music (MP3) players, like the popular iPod, may interfere with the correct functioning of pacemakers and implantable cardioverter defibrillators...
Off-Label Use of Biliary Stents
In four years alone, more than one million patients suffering from clogged arteries and veins in their legs and torsos received biliary stents that had not been tested for that use...
Security & Privacy of Implanted Devices May be Compromised Wirelessly

Some implanted medical devices may be susceptible to unauthorized reprogramming and may permit unauthorized access to personal medical information....

The FDA
    The Food and Drug Administration (FDA) is the preeminent medical regulatory system in the world....
The U.S. Congress
    In May 2008, the House Committee on Oversight and Government Reform held a hearing to explore whether FDA drug and medical device regulation should bar state liability claims....
The U.S. Supreme Court
    In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that a 1976 federal law granting the FDA authority ...
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Feature Article

MDSI Medical Device Safety Testimony
May 12, 2009

Click here to read the MDSI-FDA study.

GAO Report
Jan 30, 2009
Research Abstract
Nov 4, 2008
American Heart Association Press Release
Oct 28, 2008
Medical Device Regulation: An Introduction for the Practicing Physician
Oct 28, 2008
The past decade has witnessed an explosion in the variety, use and complexity of medical devices...
Adverse Events Associated with Off Label Use of Biliary Stents in the Peripheral Vasculature
Oct 27, 2008
Biliary stents are often used off label to treat biliary strictures associated with cancer...
Pacemakers and Implantable Cardiac Defibrillators;Software Radio Attacks & Zero Power Defenses
Oct 27, 2008
Full study analyzing the security and privacy properties of an implantable cardioverter defibrillator.
Security and Privacy for Implantable Medical Devices from Pervasive Computing
Oct 27, 2008
Implantable medical devices monitor and treat physiological conditions...
MDSI Congressional Testimony, May 2008
May 14, 2008

MDSI's Director William Maisel's testimony before the House Committee on Oversight and Government Reform.

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