 Heparin Catheter Flush Finds a Home at CDRHEffective Oct. 16, the device center will assume primary responsibility for the regulation of heparin lock-flush solution products, some of which had been under the purview of the Center for Drug Evaluation and Research. The transfer of the combination product to CDRH reflects FDA's determination that the primary mode of action is that of the device, which is used to keep intravascular catheters open and prevent blood from clotting. Heparin lock-flush solution products will now be considered 510(k) products, and must comply with the device Quality System Regulation. FDA will not assess any application user fees for the administrative transfer.
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