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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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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