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2014 Hot Spots: Top 4 Device Quality & Regulatory Topics

This article was originally published in The Silver Sheet

Executive Summary

Big changes are afoot for inspections, and device stakeholders kept a sharp eye on those issues in 2014, according to "Silver Sheet" readership data. From a CDRH/ORA plan to create a specialized unit of device-focused field investigators, to IMDRF's mostly untested internationally harmonized single-audit approach, readers (and podcast listeners) couldn't get enough news and tips about inspection activities. Further, FDA is "looking at whether information presented on FDA-483s can be organized in a way that better reflects what we consider to be highest priority quality system deviations that require the most significant attention,” CDRH compliance chief Steven Silverman said. Rounding out the top industry issues last year were device recalls, Unique Device Identification, warning letters and CAPA. A recap of in-depth "Silver Sheet" coverage from the year, including updated expert commentary, follows.


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