FDA MDUFA III Performance, By The Numbers
This article was originally published in The Gray Sheet
Here's a snapshot of FDA's current premarket device review activity in seven interactive graphics.
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The agency's device center put out a request to health insurers to make themselves available to participate in FDA pre-submission meetings so that device firms, particularly start-ups, can better understand data expectations for coverage while companies are still designing studies to support FDA approval.
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.
The most popular "Gray Sheet" stories in 2015 dug deep into regulatory developments and concepts, and provided guidance on how to respond. Quality control topics and analysis of FDA's premarket review processes dominates the list.