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Devices that are part of the Breakthrough Devices Program, have received FDA marketing authorization for the indication covered by the Breakthrough Devices designation, and meet the other criteria in the regulation can be approved through the quarterly process and announced through that process (81 FR 79655)

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Safety Considerations and Clinical Eligibility GLP-1 medications require baseline kidney function assessment (eGFR), gastrointestinal history review, and contraindication screening (personal/family history of medullary thyroid cancer or MEN2)

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