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US Approvals Analysis: July A Good Month For PMAs; 510(k)s Down In 2016

 
• By David Filmore

A look at Medtech Insight's Approval Tracker data shows that last month was a relatively active one for US FDA approvals of novel devices via the PMA, panel-track supplement and de novo routes. But 510(k) clearance totals are down so far in 2016 compared to recent years.

In July, the US FDA had its most active month of 2016 so far in approvals of novel device or indications, with 10 original and panel-track PMAs OK'd during the month, and another three de novo classifications finalized, according to Medtech Insight's Approval Tracker.

The agency surpassed its performance from April of nine original and panel-track PMAs and three de novos. So far in 2016, through July, FDA has approved 25 original PMAs, 13 panel-track supplements and 13 de novos

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