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U.S. Department of Health and Human Services

Combination Products

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Request for Designation - Review Performance

21 CFR 3.6 designates the Office of Combination Products (OCP) as the product jurisdiction officer for FDA.  Accordingly, OCP reviews and issues decisions for Request for Designation (RFD) documents submitted to the Agency. OCP posts performance data for RFD submissions.  Refer to the links below for performance data corresponding to each indicated fiscal year.  Additional information about OCP performance is also provided in OCP Annual Reports to Congress.

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Formal Requests for Designation Submitted by Industry

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