Principles of Premarket Pathways for Combination Products

On 26 January 2022 the FDA issued the final guidance for industry and FDA staff.

This guidance presents the current thinking of FDA on principles for premarket review of combination products. This guidance offers 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 remainder of this guidance focuses on how to determine which type of premarket submissions may be appropriate for combination products. The Agency has published guidance on premarket review issues relevant to specific categories of combination products and will continue to use such guidance as needed to provide more detailed information on specific premarket considerations and specific types of combination products.

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