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Drug/device combination products

Executive Summary

Final rule, published in the Sept. 3 Federal Register, redelegates authority from Commissioner Kessler to the centers for drugs, biologics and devices to require certain manufacturers to conduct postmarketing surveillance of drug/device products. A companion rule provides authority to the centers' directors, deputy directors and compliance offices to make determinations that drug/device products present an unreasonable risk of substantial harm to the public and order remedial action. A third rule provides CDER and CBER with authority to suspend temporarily the approval of a premarket approval application and to recall devices, since certain devices are assigned to these centers.
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