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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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The absorbed water then enables the hydrolysis and other degradation reactions that lyophilization was meant to prevent

[DOI] [PubMed] [Google Scholar] Wong 2006 Wong SSL, Wilczynski NL, Haynes RB

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