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If you have diabetes you should tell your doctor if you experience eye problems during your treatment
This example helps illustrate (1) the De Novo process resulting in the creation of a new product code and regulatory section, (2) the fact that novel OTC digital health products will likely require De Novo classification requests (since the majority of the classical 510(k)s predicates are prescription only/Rx), and (3) the interaction of De Novo with the 510(k) clearance pathway for follow on devices
The results of this study revealed no significant changes in the frailty biomarkers: IL-6, TNF-, and IGF-1
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