Draft Guidance for RUO Products Issued

August 1, 2011

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.

On June 1, the FDA issued a draft guidance document that proposes both to define what products are eligible to bear the RUO label and how these products may be marketed. While much of the proposal is not controversial, several elements of the draft guidance document have raised significant concerns among manufacturers, laboratories, and researchers. The proposal, through its expansive definition of “intended use,” also has implications for drug, device, and biologic companies.

Additional information available here.