Guidance for Industry and Food and Drug Administration Staff; Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product." The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) delegates to the Office of Combination Products (OCP) responsibility for resolving disputes about the timeliness of premarket review of combination products. This guidance document provides information about presenting requests for resolution of disputes about the timeliness of premarket review of combination products.