Device company settles with FDA
Device Regulation Alert: Safety, Compliance and Reimbursement News, July 28, 2008
Advanced Bionics LLC will pay $1.1 million to resolve allegations it failed to notify the FDA it changed the outside supplier or vendor it used to supply parts for its hearing device, according to an FDA release.
The FDA alleged Advanced Bionics shipped cochlear implants to customers in the US without first filing appropriate supplemental information with the agency. The failure subjected patients to potential harm because the FDA didn’t have the chance to evaluate the whether the change affected safety of the devices. The FDA also considers the devices to be adulterated.
In addition to the company’s civil fine, CEO Jeffrey Greiner will pay a $75,000 fine.
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