Record number of medical devices with marketing authorisations



In 2018, a record was set with regard to medical devices that were approved by the U.S.-based Food and Drug Administration (FDA).It means that the upward trend recorded over the last years is still continuing.

In 2018, the FDA introduced 106 new devices, replacing the former record set in 2017 that concerned 98 devices.Even then it was the first record-breaking result achieved in 40 years.

At the beginning of this year, the FDA adopted a new definition of device. It followed the changes introduced to the 21st Century Cures Act that was passed in the December of 2016. Still, it became possible to exceed the number of 101 approvals in 2018, when previous regulations were still in force.

FDA Commissioner Scott Gottlieb, M.D. and CDRH Director Jeffrey Shuren, M.D. state it in an agency statement that they need to have an ability to continually adapt their frameworks, try new approaches and - if need be - search for authorities, as science is not something that stands still.  They added that progress made in the field of material science, digital health, 3D printing and other technologies is still a driving force behind the era of innovative inventions among medical devices.


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