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We are also cognizant that some of the definitions for DMHT devices that commenters proposed, or devices commenters recommended should be payable under HCPCS code G0552, including most Class I devices (exempt from 510(k)) may not be aligned with similar terms used by other agencies and may encompass devices not evaluated or authorized by the FDA

Real-world example: This distinction explains why someone who skipped a glass of water at dinner probably isnt experiencing a meaningfully different BAC than if theyd had that glass but someone who spent three hours in the sun at a summer festival without drinking any water, then started drinking alcohol, is in a genuinely different physiological state