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FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?

This article was originally published in The Gray Sheet

Executive Summary

Approvals of PMAs and panel-track supplements, as well as de novo devices, hit a 15-year high in calendar year 2015, according to a "Gray Sheet" analysis. FDA and industry experts respond to the data; also, check out our infographic of 2015 FDA approval trends, including a tally of the firms that captured the most PMAs and 510(k)s last year, and more.


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