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Editors' Picks: Six Themes From 2014

Industry closely scrutinized FDA's premarket review performance as the agency took steps to streamline reviews and remake the U.S. postmarket surveillance system. Meanwhile: device mega-mergers accelerated; one of the most hotly anticipated medtech innovations faltered; and national elections swept in Republican control of Congress. Here is a look back at coverage and analysis from "The Gray Sheet" on six key themes for the medical device and diagnostics industry in 2014.

On the device regulatory front, 2014 was not a year of fireworks like, say, 2009 (think CDRH whistleblowers) or 2012 (think user fee reauthorization in Congress). For FDA premarket review performance, it was in many ways a year of validation and documentation – with the agency and the device industry meticulously, but, for the most part, respectfully, watching each other and watching the data to ensure their carefully crafted user-fee agreement remains a net-benefit for both sides. "The Gray Sheet" was closely watching too.

Early signs are generally positive, with backlogs of 510(k) and PMA submissions, both at record highs several years ago, dropping precipitously, and overall review times showing some promising trends. (See...

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