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Abstract

The Food and Drug Administration (FDA) has for many years focused and identified its mission regarding medical products on traditional classes and uses for products. This legacy has contributed to a sometimes-confusing set of product classification precedents that are not always straightforward or logical for the advanced products under development. Complicating this further is the fact that, although one FDA center may have historical responsibility or legal jurisdiction over a product, the medical and technical expertise necessary for the review of that product may reside elsewhere within the agency. This article provides an overview of the history of the regulation of medical products by the FDA, particularly for products that are a combination of two different and active components. It also describes some of the current initiatives and regulations that try to clarify the issues and regulatory status of this growing class of medical products.

Keywords

Combination products Background Product jurisdiction

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References

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FDA intercenter agreements. Food and Drug Administration Web site. Available at: http://www.fda.gov/oc/combination/intercenter.html. Accessed November 15, 2005.

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An Overview of the US Regulatory Environment for Drug-Device and Biologic-Device Combination Products

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