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QUOTED. Feb. 8, 2019. Scott Gottlieb.

Executive Summary

US FDA plans to take both formal and informal approaches to reviewing device applications and is willing to accept existing and post-market data, outside-of-the US data and case histories in reviewing device submissions, it says in a final "least burdensome" guidance. See what agency head Scott Gottlieb said about it here.

"The guiding principles outlined explain our approach to assuring we obtain the minimum information needed … without compromising our stringent review standards, our gold standard for assuring safety, or the scientific integrity of our decision-making process." –Scott Gottlieb, commissioner, US FDA

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