This guidance presents the current thinking of FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate.

This guidance offers general, high-level information relevant to 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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Principles of Premarket Pathways for Combination Products