When should you contact FDA about a new medical device?

Medical device companies often ask us about the best time to contact FDA for regulatory guidance. There’s a delicate balance to strike, and it’s important to consider commercial and regulatory objectives.

Approaching FDA with a pre-submission ahead of a formal premarket submission can aid the management and mitigation of regulatory risk when the type of premarket submission and/or the clinical data requirements are unclear. But when is the best time to do this?

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