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Metabolic Support and Weight Management: The injections can support a healthy metabolism, aiding in weight management goals

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Clinical relevance for human gut conditions is not established

or (2) for devices for which pass-through status will begin on or after January 1, 2020, as an alternative to the substantial clinical improvement criterion, the device is part of the FDA's Breakthrough Devices Program and has received FDA marketing authorization for the indication covered by the Breakthrough Device designation

Submitting comments to the FDA docket by July 22, 2026

Intramuscular injection Intramuscular administration involves injecting into muscle tissue