Overview of Combination Products
On October 26, 2002, Congress enacted MDUFMA I. Among other things, MDUFMA I required FDA to establish an office within the Office of the Commissioner “to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of” combination products. As required by MDUFMA I, FDA established OCP within the Office of the Commissioner’s Office of International Activities and Strategic Initiatives on December 24, 2002. Information about OCP, including the authorizing text of MDUFMA I, can be found at the OCP Web site.
MDUFMA I also requires FDA to submit an annual report to Congress on the activities and impact of OCP. This document fulfills this requirement for FY 2008. As part of reauthorizing medical device user fees under MDUFA II, FDA had no new reporting requirements on the activities and impact of OCP.
Combination products are increasingly being developed to enhance the safety and effectiveness of conventional medical products. These products are defined by any of the following criteria as in Title 21 Code of Federal Regulations (CFR) 3.2(e):
- A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that is physically, chemically, or otherwise combined or mixed and produced as a single entity;
- Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
- A drug, device, or biological product packaged separately that, according to its investigational plan or proposed labeling, is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or,
- Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
Combination products have the potential to provide enhanced therapeutic advantages compared to single entity devices, drugs, and biologics. More and more combination products are incorporating cutting-edge, novel technologies that hold great promise for advancing patient care. Combination products may include drug-delivery systems, gene therapy systems, personalized medicine drug-device combinations, biological-device combinations, nanotechnology, and other innovative products for diagnostic and therapeutic treatments of cardiovascular, metabolic, oncologic, and other disorders.
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