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Apr 1, 2011 (Vol. 31, No. 7)

Uncertainty Persists with RUO Products

FDA May Be Considering More Restrictive Approach with Research Use Only Assays

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    Pharmaceutical companies need to be aware of issues stemming from the use of RUO products. For instance, using an RUO test to help explore and understand biomarker relationships is fine, but relying on this data in a regulatory submission can be problematic.[Alexander Raths-Fotolia]

    Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed at major conferences, extensively advertised (including in GEN), and routinely used by laboratories.

    Yet, as common as RUOs are, their regulatory status is not well understood. That is not surprising because they have long occupied an anomalous regulatory position.

    The FDA adopted a regulation covering RUOs more than 30 years ago. The regulation, 21 C.F.R. § 801.109, states in full: “For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently labeled, ‘For Research Use Only. Not for use in diagnostic procedures.’”

    That is the extent to which FDA has established regulatory requirements for RUOs. If an RUO product is properly labeled, then it has fully satisfied the applicable FDA requirements.

    This very light regulatory touch is appropriate. RUOs are not medical devices and therefore are not subject to FDA jurisdiction. The statutory definition of a “device” includes products intended to be used in the “diagnosis...of disease or other conditions.” By definition, RUOs are not intended to be used diagnostically. Hence, they are not devices and therefore not within FDA’s regulatory domain. This means that the basic FDA regulatory requirements, such as premarket review, the Quality System Regulation, device listing and the submission of reports to FDA, are not applicable.


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