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September 15, 2010 (Vol. 30, No. 16)

Regulating Laboratory-Developed Tests

Task Will Require Deft Hand from FDA to Retain Innovation and Patient Access

  • The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests developed by a laboratory and offered as a diagnostic service by that laboratory are regulated at the federal ...

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