FDA Draft Guidance Would Restrict Marketing of Research Use Only and Investigational Use Only In Vitro Diagnostic Products


On June 1, 2011, the Food and Drug Administration (“FDA”) issued a draft guidance document setting forth the agency’s proposed interpretation of the law regarding commercially distributed in vitro diagnostic (“IVD”) products labeled for research use only (“RUO”) or investigational use only (“IUO”). The draft guidance calls into question certain common views regarding how RUO and IUO products may be marketed. Most controversially, it asserts that manufacturers who become aware that a laboratory customer is using an RUO or IUO product for clinical diagnostic purposes should cease sales of the product to that customer. This draft guidance document has the potential to alter business practices both of manufacturers of RUO and IUO products and the laboratories that purchase and use them. FDA is accepting comments on the draft guidance until August 30, 2011.

Products Labeled as RUO

According to FDA regulations, IVD products in the laboratory research phase of development are exempt from most regulatory requirements applicable to IVD medical devices if they are labeled “For Research Use Only. Not for use in diagnostic procedures.” Among other things, such products are exempt from FDA premarket approval, premarket notification (510(k) clearance), and good manufacturing practice requirements. The draft guidance clarifies the scope of RUO products, dividing them into two categories. The first category includes those products intended to assist with the development of a commercial IVD product. For this type of RUO product, the laboratory research phase of development involves manufacturer studies focused on the evaluation of the IVD test’s design, limited-scale test performance, and test usability. The second category includes products intended to aid in the discovery and development of basic medical knowledge related to human disease. The draft guidance specifies that products should not be labeled as RUO if they are intended for use in a clinical investigation or for clinical diagnostic use.

Products Labeled as IUO

FDA regulations establish a separate category of certain IVD products that are intended for use in clinical investigations. Under FDA’s investigational device exemption (“IDE”) regulations, a clinical study of an IVD product is generally exempt from IDE requirements if the product (1) is non-invasive, (2) does not require invasive sampling that poses significant risk, (3) does not introduce energy into a subject by design or intention, and (4) is not be used for diagnosis without confirmation by another medically established diagnostic procedure or product. IVD products tested in such IDE-exempt clinical studies may appropriately be labeled as IUO and are exempt from certain IVD requirements in addition to the IDE requirements. The label for an IUO product must read, “For Investigational Use Only. The performance characteristics of this product have not been established.”

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