Well, first, unapproved sellers may completely ignore the FDA process. “If a distributor sells a product for a foreign market, it may not meet the requirements of the US regulator,” Ledford pointed out. “[Additionally,] laboratories can’t [tell the product whether it comes from the gray market] and that’s part of the problem. Counterfeit products and counterfeit packaging are also very common in today’s global market, and the only way for labs is to make sure that their product purchases are legal Buy from authorized sources.” Buying a variety of dental products from eBay or third-party Amazon sellers is very easy, and really does not know where they come from or if they get FDA approval.
In addition to the method that completely surrounds the regulatory agency, some materials may also utilize the FDA’s so-called 510(k) process or “premarket notification.” Essentially, this process allows manufacturers to obtain FDA approval by proving that their products are “essentially equivalent” to another product on the market that has received FDA approval. But some dental market watchers said that this process may provide companies with vacancies and allow harmful products to enter the United States, where unsuspected dental laboratories and dentists can purchase them. “The U.S. Food and Drug Administration obtained data from a potential supplier [and] about the products that they are about to carry out after the approval,” explains Jay Thomas, Tosoh ceramics product manager. . Tosoh produces most of the zirconia powder used to produce zirconia disks and blocks, which means that Thomas has a keen understanding of the specifics of the zirconia market.
“As far as I know, the FDA does question these submissions. The submitter must answer the FDA’s satisfaction questions before they can finally get 510k approval,” Thomas continued. “But what we see is that any company can introduce CDs or data blocks, and basically say, ‘My products are comparable to other companies that have obtained 510k approval. Therefore, FDA approves the submitter because FDA’s The data and answers are satisfactory.
“The FDA does not have enough resources to track each of these products [Request 510(k) approvals,” he said. “[Observers] can see who got the 510K approval, who did not approve, and many products from overseas. If the FDA does not plan to check them, for example, in China, then it is worthy of attention. Somehow tightened.”
This obviously has a major impact on the safety of dental products. When asked to comment on the removal of zirconium oxide and the 510(k) approval process, the FDA stated in an e-mailed statement: “The FDA is concerned about the gray market sales of legally marketed dental products. We have been working hard with certain types of dentistry. The Product Resale website together helps identify any illegally-sold equipment on the site for resale so that they can remove it from their website. We also encourage manufacturers and medical professionals to report to FDA any instances that appear to be equipment sales. It is important to note that although FDA regulates the safety and effectiveness of dental instruments through premarket approval and approval of legally sold medical devices, it does not regulate dental practice. All dental instruments that enter the FDA through the 510(k) pathway Applications will be thoroughly reviewed to determine substantial equivalence. ”