FDA Scrutiny Looms For Unapproved Research Tests

Law360, New York (November 25, 2013, 8:45 PM EST) -- The U.S. Food and Drug Administration on Monday edged away from controversial plans to force manufacturers of unapproved diagnostic tests sold for research purposes to ensure that their customers don’t use the products for commercial purposes, but there’s still plenty of reason to believe that stronger enforcement is on the horizon, experts say.

In finalized guidance, the FDA deleted a provision saying it “may consider a manufacturer’s knowledge of the purposes for which its customers offer and use its [in vitro diagnostic] product” when deciding whether...
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