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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

PMID 15883631

Bioidentical Hormone Replacement Therapy (BHRT) is the process of supplementing our natural hormone production with bioidentical hormones

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