Investigating Dental Devices: Dr. Krauthamer on FDA Processes

April 10, 2023

Dr. Victor Krauthamer

KHN and CBS News conducted a joint investigation into the dental appliance, the Anterior Growth Guidance Appliance (AGGA), “that multiple lawsuits allege caused grievous harm to patients.” This appliance was never registered with the FDA and did not get on their radar until Cara Tenenbaum, former senior policy advisor in the FDA’s agency device center, brought the FDA to begin this investigation. After her work with KHN and CBS News, many other FDA officials became concerned and “said they have begun ‘looking into’ the AGGA but have yet to determine how much legal authority the agency has to regulate it.”

In the article, “FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm,” Victor Krauthamer, GW Visiting Professor of Biomedical Engineering and “former FDA official who worked in a division regulating medical devices at the agency for three decades, said it was normal for an FDA probe of a device to begin by researching the boundaries of the agency’s authority, ensuring any future action has a solid legal foundation. Krauthamer said he expects the FDA to take regulatory action against the AGGA, including sending a warning letter to the manufacturer and potentially taking custody of the devices.”

“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.