“Research Use Only” Reagents: Is There an Imperative for Increased FDA Oversight?

Abstract

On June 1, 2011, the US Food and Drug Administration (FDA)2 Office of In Vitro Diagnostic Device Evaluation and Safety issued draft guidance for industry and FDA staff intended to provide guidance regarding the FDA's thinking about in vitro diagnostic device (IVD) products labeled for “Research Use Only” (RUO) or “Investigational Use Only” (IUO) (1). Reagents may be marketed under either of these labels without FDA premarket review and are partially or totally exempt from compliance with the Quality Systems Regulation (21 CFR 820). Therefore, an IVD manufacturer might it very tempting to avoid the trouble and expense of a 510(k) or premarket-approval submission by labeling a product as RUO or IUO, despite knowing full well that the product is likely being used as an IVD under conditions in which there is no research protocol and no oversight by an institutional review board. There is no doubt that the FDA's intent is to improve patient safety. Compliance with the Quality Systems Regulation provides assurance that an IVD meets manufacturing specifications and that lot-to-lot variations are minimized and well understood. FDA clearance provides further assurance that the performance characteristics of laboratory tests are sufficiently well understood as to enable their intelligent use. Furthermore, the use by clinical laboratories of FDA-cleared IVD products likely reduces interlaboratory variation in testing and increases the ease with which results can be “ported” from one healthcare facility to another, potentially reducing healthcare costs that arise from duplicate testing. Nevertheless, the laboratory community is right to be concerned about the guidance document statement that manufacturers should not sell RUO or IUO reagents “to laboratories that they know use the product for clinical diagnostics use.” This statement could have unintended consequences that adversely affect patient care. In particular, the molecular diagnostics community has expressed concern that such …