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
- Find out more: US FDA Emphasizes Computer Modeling, Existing Data For Least-Burdensome Device Submissions
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