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Heres a visual breakdown of the pathways (including the Medical Device User Fee Amendments) for comparison: Ideally, youll be thinking about your regulatory strategy during design and development, as changes to the device may change its risk, and therefore your regulatory pathway

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Local circularity represents a shift from macro-scale, resource-centric models to site-specific, community-embedded practices (Kocaturk and Hosseini, 2023)