Nothing worries device manufacturers so much as a major recall. In the February 2011 issue of "The Silver Sheet," it was re-vealed that FDA worries about recalls, too - namely, why there was a large increase in class I device recalls in 2010. That story garnered the most interest from our online readers last year. Also popular were stories on FDA's vision of a potential path to better product quality, and on making sure that qualified individuals oversee process validation:
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