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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66

[1,8] The vast majority of this research has been conducted in animal models

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Experiences and translatability of in vitro and in vivo models to evaluate caprate as a permeation enhancer

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