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U.S. Department of Health and Human Services

Combination Products

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Intercenter Agreements

 

In 1990, Congress amended the Federal Food, Drug and Cosmetic Act (the Act) to introduce the concept of combination products and to begin to clarify product jurisdiction issues. Shortly thereafter, in 1991, the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH), entered into three Intercenter Agreements ( ICAs). However, in 2005 the Agency issued a final rule for Primary Mode of Action (PMOA) [PDF] (21 CFR Part 3), which governs jurisdictional decisions.  In 2006 (71 FR 56,988 [PDF]), the Agency reviewed these agreements and preliminarily determined that they continue to provide helpful, nonbinding guidance, and proposed to continue them in effect, with the understanding that they should not be independently relied upon as the Agency's most current, complete jurisdictional statements.  The Agency suggests that persons wishing to get the most current information also consult the various other sources of information about jurisdictional determinations.  For more information, refer to the jurisdictional update on Intercenter Agreements.

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