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U.S. Department of Health and Human Services

Combination Products

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Guidance & Regulatory Information

The Office of Combination Products develops regulations and guidance for combination products.  The links at the left of this page provide more information about combination product regulations and guidance.  Also provided is a link to the procedures that FDA follows for the intercenter review of products.

 

Contact FDA

301-796-8930
Fax:301-847-8619
Office of Combination Products

Food and Drug Administration

WO32, Hub/Mail Room #5129

10903 New Hampshire Avenue

Silver Spring, MD 20993
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