Draft Guidance for Industry on Combination Products, Timeliness of Premarket Reviews, Dispute Resolution; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Combination Products, Timeliness of Premarket Reviews, Dispute Resolution Guidance." 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.