safety or efficacy

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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 Read more

By | 2011-08-05T19:07:39+00:00 August 5th, 2011|Media Reports, Medical News|0 Comments