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Scott Gottlieb, M.D. @SGottliebFDA
, 4 tweets, 2 min read Read on Twitter
THREAD: Today we’re announcing the next phase of our Pre-Cert Pilot Program to test new approaches for the review of digital health devices to help support the development of new technologies that meet our safety and effectiveness standard. go.usa.gov/xE2m9
We’re releasing our Regulatory Framework that describes how we intend to use our De Novo pathway for novel technologies to implement the next phase of the Pre-Cert pilot. go.usa.gov/xE2Vn
We’re also issuing our Pre-Cert Test Plan for 2019 to assess how using a streamlined De Novo pathway compares to the traditional pathway, ensuring it can maintain our standards for assuring safe and effective devices, while still modernizing our review. go.usa.gov/xE2VX
We’re also updating our Pre-Cert Working Model to incorporate the Framework and Test Plan so we can understand how well Pre-Cert will work now, and also help establish the components we envision for the future of Pre-Cert. go.usa.gov/xE2V9
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