In medical product regulation, like lawnenforcement, determining jurisdiction isncritical to avoiding confusion and inefficiency.nBut “border crossings” betweenndrugs, biologics, and devices—categoriesnthat follow distinct regulatory paradigms—nare making assigning regulatory authoritynfor products more difficult.nA relatively new department in the FDAncalled the Office of Combination Productsn(OCP) is charged with handling this issue.nFormed in December 2002 at the behest ofnthe Medical Device User Fee andnModernization Act, OCP is the internalnand external “go-to point” for resolvingnjurisdictional questions andnfacilitating consultations between historicallyndisengaged FDA centers, saysnOCP director Mark Kramer.
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