Regulatory Considerations For Nanotechnology Products 861 Jurisdiction of Nanotechnology Products

There has been much interest in the question of whether nanotechnology products will be considered drugs, devices, biologics or a combination of the three for regulatory purposes and assignment of work. This has been extensively discussed internally within the FDA and the current thinking is that many of these products will be considered combination products.

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, more effective, or more convenient to patients. For example, 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.

Because 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 the 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 December 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.

A combination product is assigned to an agency center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Under section 503(g)(1) of the act, assignment to a center with primary jurisdiction, or a lead center, is based on a determination of the "primary mode of action" (PMOA) of the combination product. For example, if the PMOA of a device-biological combination product is attributable to the biological product, the agency component responsible for premarket review of that biological product would have primary jurisdiction for the combination product.

A final rule defining the PMOA of a combination product was published in the August 25, 2005 edition of the Federal Register, and is available at http://www.fda.gov/oc/combination/. The final rule defines PMOA as "the single mode of action of a combination product that provides the most important therapeutic action of the combination product."

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