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FDA’s 510(k) Process Under Scrutiny

By Santhosh Nair In September of 2009 the FDA commissioned an independent committee review of its 510(k) process, the most common method medical device manufacturers use to bring lower-risk products to market.  In their resultant report, the Institute of Medicine (IOM) recommended a complete overhaul.  Although the FDA has dismissed the recommendations, they are continuing to refine the 510(k) process.…