Because some diagnostic devices can have many different claims and uses, it is often difficult for companies to determine when they need to separately market different applications of the same device. FDA's recently released guidance document, Molecular Diagnostic Instruments with Combined Functions, aimed to clarify the rules applicable to molecular diagnostic devices. "Molecular diagnostic instruments" are defined in the guidance as "critical components of certain in vitro diagnostic devices (IVDs) ... [that] are not generally approved/cleared alone, i.e., without an accompanying assay, because their safety and effectiveness or substantial equivalence cannot be evaluated without reference to the assays they run." In response to industry concerns about marketing and approvals for multiuse devices, FDA stated, "[t]he same instruments may ... be used for additional purposes that do not require FDA approval or clearance, such as for basic scientific research-purposes" and do not require separate marketing.
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