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New “Research Use Only” Rules

FDA is poised to limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products, issuing draft guidance to that effect on Tuesday.

RUO products are usually in the laboratory research phase of development or are used as basic scientific research. But some companies sell these products when they know or should know that they are being misused diagnostically. Now, the FDA will require that companies only sell their RUO or IUO products if they know or have reason to know that the product is actually being used diagnostically. In other words, no more turning a blind eye to what you know or assume the company’s purpose for a product. The “hey, we make no diagnostic claims are being made” skirt is off.