PMA Approvals On Track For 15-Year High
This article was originally published in The Gray Sheet
The agency has so far approved a total of 36 original PMAs and panel-track supplements in 2015, the highest total at this point in the year since 2001.
You may also be interested in...
FDA MDUFA III Performance, By The Numbers
Here's a snapshot of FDA's current premarket device review activity in seven interactive graphics.
In Case You Missed It: Top 10 "Gray Sheet" Stories In August
Our feature exploring the myriad complications of the ongoing revision process for the international device quality systems standard ISO 13485 attracted the most "Gray Sheet" Web traffic by a long shot last month. Also popular: stories on a gap in warning letter postings; a Google device spinoff; China device reforms; and more.
Business Briefs: Knee, Obesity Approvals, And A Deal Roundup
Key approvals for Stryker and Apollo Endosurgery, and deals by Boston Scientific, Illumina, Abbott and Lombard Medical.