Principles of Premarket Pathways for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled "Principles of Premarket Pathways for Combination Products." This guidance presents FDA's current thinking on principles for premarket review of combination products. This guidance includes general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The guidance also includes recommendations on how to determine which type of premarket submissions may be appropriate for combination products. FDA is publishing this guidance as part of its efforts to implement the 21st Century Cures Act (Cures Act) and in keeping with the Agency's long-standing commitment to transparency, efficiency, and regulatory consistency to facilitate development of safe and effective combination products. This guidance finalizes the draft guidance of the same title that published on February 6, 2019.