California device maker in trouble with FDA
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 14, 2008
The FDA is seeking civil penalties exceeding $2 million from Advanced Bionics, LLC, a California manufacturer of hearing aids and Jeffrey H. Greiner, the company’s president and co-CEO, according to a March 28, 2008, press release.
The FDA filed a complaint last November and amended it last month, making several allegations relating to a component of the device. According to the press release, the device, a cochlear implant that is implanted behind a patient’s ear to treat hearing loss, poses a risk due to excessive moisture that can result in device failure and adversely affect patients.
The FDA claims Advanced Bionics failed to file supplemental information with the FDA before shipping hearing aids to U.S. customers and Advanced Bionics used a device component from an unapproved vendor. The FDA also claims the company failed to:
- Provide notice of a change in vendor to the FDA
- Properly evaluate the new vendor, comply with the Good Manufacturing Practices for devices
- Validate the safety and effectiveness of the device with the new component
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