Top 15 In '15: The Most-Read "Gray Sheet" Stories Of The Year
This article was originally published in The Gray Sheet
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.
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Here's a snapshot of FDA's current premarket device review activity in seven interactive graphics.
The agency's device center is in the midst of adopting a "Smart" 510(k) template to improve reviewer-to-reviewer consistency and speed up the learning curve for new reviewers. It is part of a broader IT push at the center to further standardize industry submissions and how they are reviewed, the Office of Device Evaluation's Barbara Zimmerman tells "The Gray Sheet."
The agency is taking another stab at clarifying its views on when a 510(k) is needed for a device modification in a draft guidance it hopes to issue next year, after having to abandon its 2011 effort in the face of stakeholder revolt. The device center's Michael Ryan previews what to expect.