Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance

Original source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626838.htm