The FDA has announced that a settlement has been reached with a California device manufacturer and its president over alleged federal law violations. The violations involved the failure to notify the FDA of a change of outside supplier or vender. This could have exposed patients to unnecessary health risks, such as device failure and surgery.
Advanced Bionics originally received FDA approval to market an implant that was surgically placed under the skin behind the ear to treat profound hearing loss in adults and children.
The FDA filed a complaint against advanced Bionics in November of 2007 and amended it July 7, 2008, alleging that Advanced Bionics shipped the implants without first filing appropriate supplemental information with the FDA. The failure to submit supplemental information prevented the FDA from being able to evaluate the impact of the changes on the safety and effectiveness of the device. The FDA therefore considered these devices to be adulterated, since they were no longer covered by the agency’s original product approval.
Advanced Bionics agreed to settle the complaint without admitting liability and must remit payment to the U.S. Treasury within 10 days of settling.