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US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends

 
• By David Filmore

The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all US and non-US approvals and clearances in 2017 and previous years, check out our Approvals Tracker.]

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