Posts Tagged ‘ New York Times ’

Tort Reform and You

Apr 16th, 2013 | By
Tort Reform and You

April 16, 2013 ~ We generally don’t discuss politics on MDND because the community of medical device-injured patients is united by the common denominator of pain and a sense of injustice. Everything else is secondary. But I’d like to share some thoughts about the movements underway in the country as I just returned from Mass
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How Safe Are Medical Devices?, New York Times, August 4, 2011

Aug 5th, 2011 | By
How Safe Are Medical Devices?, New York Times,  August 4, 2011

This Opinion Page Editorial in the New York Times reports the “substantial equivalent” standard of the 510(k) process doesn’t work because some devices reach back 35 years and were never assessed for safety or efficacy. The article, dated August 4, 2011 can be found here. (may require Log In and subscription) “The committee found no
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.