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Advanced Bionics, FDA reach settlement

This article was originally published in The Silver Sheet

Executive Summary

Cochlear implant maker Advanced Bionics has settled with FDA over agency allegations that the firm violated quality system regulations and failed to properly submit a PMA supplement when it added a vendor for a component of its HiRes90K implant ("The Silver Sheet" May 2008). Under the July 14 agreement, neither Advanced Bionics nor CEO Jeff Greiner admits liability. However, the company will pay FDA a civil money penalty of $1.1 million, while Greiner will pay $75,000 - considerably less than the $2.2 million in fines the agency requested in its original complaint, filed in November 2007
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