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In the CY 2020 OPPS/ASC final rule with comment period, we finalized an alternative pathway for devices that are granted a Breakthrough Device designation (84 FR 61295) and receive FDA marketing authorization for the indication covered by the Breakthrough Device designation

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However, variations in liver efficiency and enzyme activity among individuals mean that some people may metabolize alcohol more quickly or slowly than others, leading to differences in BAC levels after consuming the same amount of alcohol

doi: 10.1016/0165-6147(86)90420-7