Furthermore in more elaborative way, the term combination product includes:

1. A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

2. 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;

3. 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

4. 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.

Technological advances in drugs, medical devices, and biologic-based products continue to lead to the development of products aimed at improving patient outcomes and extending human life. Marrying two or more of these healthcare products into a combination product, such as a drug-eluting stent, demonstrates patient benefits like :

• Innovative ways to extend lifecycles of existing products for manufacturers

• Reduced toxicity in patients

• Fewer side effects for patients

• Higher rate of efficiency

• Improved patient compliance

Combination Products: Categorization

Traditional drug-delivery systems combine or package drugs together with injection devices to improve convenience of administration. This includes prefilled syringes, pen-based delivery systems, drug pumps, and autoinjectors. Because the drug-device interface is relatively simple in these products, the components can be developed separately and then integrated during later stages of their development cycles. These components can also be regulated separately using the established regulatory regimes for drugs and devices.

Novel drug-delivery systems (e.g., patches, transdermal or intradermal injections, inhalation devices, sprays, and drug-eluting disks) typically combine existing drugs with new delivery devices. These are designed to improve convenience and comfort of administration, improve drug effectiveness through localized administration, or enable delivery of a drug through a nontraditional route (other than oral or subcutaneous and intramuscular injections). Although the complexity of these products is typically moderate, changes to administration, drug formulation, and bioavailability can increase the technology of drug development. Because their primary therapeutic mode of action is drug related, these products are primarily governed by the regulatory pathway for drugs.

Drug-enhanced devices, such as drug-eluting stents, coated catheters, anti-infective sutures, bone cements with antimicrobial agents, and other devices with antimicrobial coatings enhance the functionality, efficacy, or performance of devices. In many cases, these products combine existing devices with existing drugs. Although the complexity of the device component could vary depending on its function, the drug-device interface is often novel and is critical to the performance of the combination product. Consequently, development is much more complicated than similar device-only products. Because the primary therapeutic action stems from devices, device regulators primarily govern these products, with a secondary review from drug-related regulatory agencies.

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