On July 14 2011, the FDA Center for Device and Radiation Health (CDRH) posted a Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices. This draft guidance is a welcome clarification of the FDA’s position on this matter which has remained somewhat ill-defined until now. Indeed, the rather antiquated rules applying to the approval for commercialization of medical devices have been, to put it mildly, ill-suited for the development of IVD. Briefly, the rules used by the CDRH were primarily designed to control the commercialization of instruments (e.g. imaging, surgical, drug delivery) which pose direct physical risks to the patients (see CDRH milestones for a timeline). In contrast, diagnostics and laboratory products impact patient health indirectly: those devices cannot directly harm the patients but the decisions driven by those devices can have a profound impact on the choice of treatment and therefore on the patient health. Hence, the risk posed by IVD is generally much more difficult to gauge. I would argue that the co-development of companion IVD and a new drug is even more challenging since the risk / benefit of the drug and the IVD are evaluated in parallel with little or no prior knowledge. Hence, a modernization of this process is urgently needed.
Combined with the recent independent report from the Institute of Medicine about the FDA CDRH 510 k process (see previous post), this draft guidance on Companion IVD seems to indicate that the FDA CDRH is trying to catch up with the evolution of the field.
Thierry
Sornasse for Integrated Biomarker Strategy
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