September 1, 2011

FDA urged to replace 510(k) process

By: OR Manager
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OR Manager; Vol. 27 No. 9; September 2011 The Food and Drug Administration should replace its 35-year-old 510(k) process for medical devices, the Institute of Medicine (IOM) urges in a new report. The IOM finds the process is flawed as a means to screen…

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