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The FDAs post-market obligations for Class II devices cleared via 510(k) are primarily passive MDRs (Medical Device Reports) filed when malfunctions or serious adverse events occur, plus any conditions imposed through the clearance letter

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Discontinuation should be considered if appetite suppression or weight stabilization does not occur after 34 months at higher doses

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Thus, more studies are needed to fully understand the consequences of untreated MASLD on diabetes development and to find ways to prevent or lessen the impact of both diseases

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