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March 01, 2010 (Vol. 30, No. 5)

Oversight of Research Use Only Products

RUO Assays and Instruments Face Greater Scrutiny

  • The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) products are essentially unregulated. In fact, although RUO products are often discussed as though they are a kind of ...

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