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A statement of the reasons for not classifying or retaining the device in class III may be in the form of concurrence with the reasons for the recommendation of the classification panel, together with supporting documentation and data satisfying the requirements of 860.7 and an identification of the risks to health, if any, presented by the device

All data are representative of at least three independent experiments

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Timing considerations for GLP-1 medications apply broadly across formulations, though individual patterns vary