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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.
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.
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.
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.
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