I’ve been asked by several persons, “Why did the Food and Drug Administration sue Advanced Bionics?” The answer, as concise is possible, is as follows.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Implant. Worth noting, a cochlear implant is classified as a Class III medical device by the FDA, and Class III medical devices are the most stringent regulatory category for devices.
The FDA alleged that Advcanced Bionics failed to comply with the FDA’s current Good Manufacturing Practice (GMP) requirements for devices. In a sense, the GMP requires a company manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.
The FDA alleged (among others) that Advanced Bionics:
- Failed to sufficiently evaluate and select a new vendor as the supplier of a critical device component of the HiRes90k implant and further failed to validate the continued safety of the HiRes90k when an unapproved vendor’s component was used.
- Shipped cochlear implants in violation of the law between January 2005 and July 2006, specifically that two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
- Failed to file required supplements with the FDA.
So, in a nutshell, Advanced Bionics got pre-market approval (PMA) from the FDA to sell the HiRes90k using Vendor A as a supplier. After obtaining PMA, Advanced Bionics added Vendor B as a supplier. Allegedly, Advanced Bionics never received approval to use Vendor B.
And there, in a short version, is why the FDA sued Advanced Bionics.
If you believe you have been physically or emotionally injured as a result of the Advanced Bionics clarion HiRes90k cochlear implant, please call Tim Edwards or Ed Wallis at (901) 527-4673, or SEND US AN E-MAIL today.
You can also click HERE for more information.
