FDA Approved 106 Novel Medical Devices In 2018

During 2018, the U.S Food and Drug Administration (FDA) approved or cleared 106 novel medical devices, up from 98 in 2017. Since 2009, the FDA has quadrupled the number of annual device approvals, from 25 in 2009 to the current 106. The FDA originally defined novel devices only as original premarket approval (PMAs) applications, panel track supplement PMAs, and de novos. Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions. For 2019, the FDA broadened the definition to include Humanitarian Device Exemptions (HDEs) and Breakthrough Device 510 . . .