USFDA is implementing a vigilant post-market surveillance system by initiating new device monitoring steps starting now and through early 2019, to quickly identify new or increased safety concerns with medtech products, Commissioner Scott Gottlieb said Nov. 20.
“After carefully considering public feedback, we’ll be announcing in a series of updates several important new actions that will help FDA continue to enhance our nationwide [medical device] post-market surveillance...
Up Next: 510(k)s
In conjunction with its safety action plan announcement, Gottlieb said that, next week, FDA will announce "additional actions aimed at fundamentally modernizing the process for medical device review,...