In the article, “FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm,” KHN reported on the Anterior Growth Guidance Appliance (AGGA) that was recently bought to the FDA's attention as it was never registered with the agency and has spurred multiple lawsuits alleging the device has caused harm to patients. Reporters interviewed Dr. Victor Krauthamer, a visiting biomedical engineering professor at GW, for his thoughts on the FDA's next steps as he spent three decades working there.
Here is an excerpt from the article: “At this point, I would be surprised if there wasn’t some sort of compliance action, such as a seizure,” Krauthamer said, adding later, “I think that’s probably where the FDA is - trying to make a case that will hold in court and won’t be thrown out.”
Read the full article on KHN.