Patients, dentists can report to FDA issues with direct to consumer dentistry devices
October 15, 2018
Patients and dentists can report issues with medical devices to the U.S. Food and Drug Administration, including any problems they have had with devices related to direct to consumer, or DTC, dental laboratory products.
The use of these products is sometimes referred to as do-it-yourself, or DIY, dentistry.
The FDA’s MedWatch voluntary reporting form can be used to inform the FDA about problems patients encounter with DTC products, such as aligners, partial dentures and snoring appliances. More general information about the FDA medical device reporting program can be found on the FDA's website.
The ADA launched earlier this year a public awareness campaign on the potential concerns to patients when using DTC appliances or DIY treatments. These include teeth-straightening kits, veneers, bruxing devices and other solutions typically executed under the care of a dentist or specialist.
On Aug. 3, the ADA ran a full-age ad in the Wall Street Journal encouraging readers to visit an ADA dentist to avoid serious potential problems from DTC dentistry.
In 2017, the ADA House of Delegates passed a policy saying the Association “strongly discourages” the practices of DTC orthodontics because of the potential harm to patients.
A resolution the 2018 House of Delegates will consider states that the “ADA strongly discourages the practice of direct to the consumer dental laboratory services because of the potential for irreversible harm to patients.”
Members can review all resolutions under consideration on ADA.org (ADA member login required).