510(k) Substantial Equivalence Decision-Making Tool

The 510(k) Substantial Equivalence Decision-Making Flowchart for medical devices has served as the overarching framework for the FDA’s premarket notification (510(k)) decision-making for decades. It provides a concise summary of the 510(k) decision-making process, and it has served as a common frame of reference for scientific and regulatory discussions related to the 510(k) process.

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