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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

And then the thymosin peptides, the thymosin beta-4 and thymosin alpha-1 have been peptides that have been around for quite awhile

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