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.
[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.]
October was a relatively light month for FDA approvals, with two original PMAs, one panel-track supplement and one de novo...