Diagnostic Testing Fight Puts FDA In A Pickle

By Jeff Overley (June 6, 2014, 7:05 PM EDT) -- The U.S. Food and Drug Administration is facing pressure to let more diagnostic testing tools be used in doctors' offices, placing regulators in the middle of a feud between device manufacturers eager to boost sales and sophisticated laboratories that stand to lose business.

Debate centers on how to interpret the Clinical Laboratory Improvement Amendments of 1988, which allow in vitro diagnostics — such as devices that analyze blood or saliva — to obtain a waiver for use in doctors' offices and clinics if they are deemed to be "simple" and to pose an "insignificant risk of an erroneous result."

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