2018 US Device Approvals: The Year Of De Novos And Digital Health

14 Jan 2019

• By David Filmore

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

FDA approved background, 3D rendering, blue street sign

[Editor's note: For sortable and searchable tables of all US and non-US approvals and clearances in 2018 and previous years, check out our Approvals Tracker. For comprehensive tracking of company events and catalysts related to approvals and clearances, go to Meddevicetracker. Not a subscriber? Click here to request your free demo.]

The number of original PMA approvals – the regulatory pathway most typically linked to new breakthrough devices – dropped precipitously...