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Combination products (i.e., drug-device, drug-biologic, and device-biologic products) are increasingly incorporating cutting edge, novel technologies that hold great promise for advancing patient care. For example, innovative drug delivery devices have the potential to make treatments safer or more effective, or more convenient or acceptable to patients. Drug-eluting cardiovascular stents have the potential to reduce the need for surgery by preventing the restenosis that sometimes occurs following stent implantation. Drugs and biologics can be used in combination to potentially enhance the safety and/or effectiveness of either product used alone. Biologics are being incorporated into novel orthopedic implants to help facilitate the regeneration of bone required to permanently stabilize the implants.
Stakeholders report that FDA can expect to receive significantly more combination products for review as technological advances continue to merge therapeutic products and blur the historical lines of separation between FDA's medical product Centers. Since combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they also raise challenging regulatory, policy, and review management issues. A number of criticisms have been raised regarding FDA's regulation of combination products. These include concerns about the consistency, predictability, and transparency of the assignment process; issues related to the management of the review process when two (or more) FDA Centers have review responsibilities for a combination product; lack of clarity about the postmarket regulatory controls applicable to combination products; and lack of clarity regarding certain Agency policies, such as when applications to more than one Agency Center are needed.
To address these concerns, FDA's Office of Combination Products (OCP) was established on Dec. 24, 2002, as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The law gives the Office broad responsibilities covering the regulatory life cycle of drug-device, drug-biologic, and device-biologic combination products. However, the primary regulatory responsibilities for, and oversight of, specific combination products will remain in one of three product centers -- the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health -- to which they are assigned.
Office duties include:
The Office also has assumed the functions of the Combination Products Program begun in 2002 within the FDA Office of the Ombudsman. Among these functions: