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August 01, 2011 (Vol. 31, No. 14)

Draft Guidance for RUO Products Issued

FDA Seeks to Better Define When and Where Research Use Only Designation Can Be Used

  • For decades, products labeled for research use only (RUO) have been widely sold and used in the United States, playing a pivotal role in the development of new diagnostic tests. During this period, neither the definition of this class of products nor the marketing restrictions have been well-defined. (See ...

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