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FDA Week - 02/08/2019

Final FDA Guide Applies Least Burdensome Review To Device Lifecycle

February 04, 2019
In final guidance released Monday (Feb. 4), FDA lays out how it will apply least burdensome provisions of medical device review to a device’s total product lifecycle, rather than just the premarket phase, while still ensuring devices meet safety and efficacy standards. The final guide, according to FDA Commissioner Scott Gottlieb, explains how FDA intends to balance and prioritize medical device safety while allowing for innovation. The guidance, “The Least Burdensome Provisions: Concept and Principles,” replaces a 2002 guidance on...


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