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Exponent Client Alert: New FDA Guidance for Combination Products

News

January 28, 2013


The regulatory pathway for combination medical products in the United States is not always clear, and there are no specific FDA regulations that govern approval of combination products. Regulatory approval or clearance of a combination product revolves around determination of the primary mode of action (MOA). The MOA of a combination product typically determines which FDA center will review the submission for approval or clearance (i.e., CDRH, CDER, CBER, etc.), and which set of regulations govern the design, manufacture, and commercialization of the product. 

Read more about the Recent FDA Rule on Current Good Manufacturing Practice Requirements for Combination Products as well as the New FDA Guidance for Postapproval Modifications to Combination Products.