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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

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Heavy drinkers metabolize alcohol faster by enzyme induction rate, but not in a way that reduces impairment, prevents BAC elevation, or protects the liver from cumulative damage