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FDA concerned about sale of dental products on gray market

October 19, 2015

By Kelly Soderlund

Editor's note: This is the third story in a series focusing on the gray market and how it affects dentists, patients and manufacturers.

Determining which dental products sold on the gray market are legal in the United States is a complicated process but the U.S. Food and Drug Administration has a number of measures in place to ensure dentists are treating patients with safe and effective medical devices.  

The FDA is in charge of approving medical and dental devices for sale in the United States and the ongoing regulation of those devices for safety and effectiveness. Despite its strict pathways to approval and ongoing monitoring of medical devices, FDA officials say they are aware of dental products being sold outside of the established distribution chain and are working to combat and shut down any illegal sales.

"The FDA is concerned about the gray market sale of legally marketed dental products," according to an emailed statement the FDA sent to the ADA News. "We have been working with certain dental product resale websites to help identify any illegally marketed devices that are on the site for resale so they can remove them from their sites."

But, as the name implies, it's not always as clear as black and white. Sometimes, suppliers buy products that were originally intended for a foreign market and don't comply with U.S. laws and regulations. If the supplier imports and then sells the product in the United States, it would be doing so illegally, according to the FDA.

But if the product is identical to what's legally marketed in the U.S., gray market sales may not violate any FDA-related requirements. However, versions of products sold in the U.S. may be different than ones sold overseas, even if they have the same name, and in that case, the foreign market device would be considered unapproved in the United States and any sales would be considered illegal, the FDA said.

There are two pathways to approve medical devices in the United States: 510(k) and premarket approval. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers that must register to notify the FDA of their intent to market a medical device at least 90 days in advance.  

This gives the FDA time to determine whether the device is equivalent to a device already approved. Examples of dental products that have received 510(k) clearance are dental caries detectors, ultrasound scalers and X-ray devices, according to the FDA.

Premarket approval is the most stringent type of device marketing application required by the FDA. The FDA determines whether the application has "sufficient and valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use," according to the FDA. Bone graft materials have received premarket approval.

The FDA encourages manufacturers and medical professionals to report any instances of device sales that appear to be illegally marketed without FDA review, the FDA said. The agency also encourages professional associations, such as the ADA, to raise awareness of gray market products and issues to ensure medical professionals and manufacturers are educated and in compliance with the law.

The FDA does as much as it can to regulate and monitor the legal sale of dental products but the agency feels it's important to note that the agency "does not regulate the practice of dentistry.

"The ADA is trying to do its part to educate dentists on the risks and pitfalls of purchasing a dental product off the gray market," said Dr. Daniel Meyer, ADA chief science officer. "We're appreciative that the FDA does what it can do regulate and monitor medical devices but, in the end, it's up to dentists to make smart and educated decisions when deciding where and how to purchase their dental products."