Responsible for protecting public health, the Food and Drug Administration (FDA) has long been actively involved in overseeing the manufacturers of dental laboratory materials. Historically, however, it has paid minimal attention to dental laboratories--until now.
In light of the dramatic rise in imports from overseas laboratories in the past several years, the FDA has become concerned that these low-cost offshore restorations might not contain FDA-approved materials that are legally required to ensure patient safety. As a result, it is taking a closer look at foreign laboratories and consequently, domestic operations.
In addition to dental materials, the FDA regulates manufacturing processes but not the final product. One key area of FDA concern is compliance with its Good Manufacturing Practice (GMP) requirements and Quality System regulations outlined in Title 21 Part 820 of the Code of Federal Regulations, often referred to as "21 CFR Part 820." The GMP requirements are wide ranging and relate to all manufacturers; the 21 CFR Part 820 regulations are specific to medical device manufacturers, which include dental laboratories.
Simply put, 21 CFR Part 820 specifies that you must have an established, documented "quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices intended for commercial distribution in the U.S." While these regulations have been in effect since 1997, it's only recently that the FDA has begun inspecting U.S. laboratories to ensure compliance.
Laboratory owner John Collins, CDT, MDT, who recently had an FDA inspection, believes it was due to the fact that he's registered as a U.S. broker for a foreign laboratory (which the FDA requires*). Well aware of the GMP regulations, Collins had implemented a number of procedures outlined in Dental Appliance Manufacturers Audit Scheme (DAMAS), a comprehensive quality management system developed in Britain and to which the NADL owns the North American rights.
"We're not DAMAS-registered but we're DAMAS-compliant so we had a lot of documentation and standard operational procedures in place. Fortunately, the inspection process went relatively smoothly for us and we didn't have any violations," says Collins, Cornerstone Dental Laboratories, Huntingdon Valley, Pennsylvania, who is working with a quality management consultant to further research compliance issues.
Dale Dental in Richardson, Texas was also inspected by the FDA. The May 2004 inspection occurred without warning; an FDA inspector simply showed up at the laboratory and spent the day talking with the facilities coordinator about the laboratory operations and its quality management procedures. "She returned the next day for further investigation and even came armed with a portable printer, and printed out a warning letter on the spot," explains President Dave Lesh.
Dale Dental works exclusively with other laboratories and one of its services is to package small amounts of porcelain to be returned with its copings. Because the FDA has regulations as to how to repackage and relabel medical products, it cited the laboratory for several repackaging violations and gave Lesh 15 days to respond and explain how he was going to correct the situation.
Lesh hired a quality management consultant, Carter Thompkins, vice president, client operations, Integrated Management Systems, and with his assistance, is in the midst of becoming ISO 9000 certified. Although the process is extensive, time consuming and costly, Lesh feels it's the best way to meet and perhaps even exceed the FDA's 21 CFR Part 820 requirements and to avoid future FDA warnings and fines.
Both Collins and Lesh hired consultants because they felt it wasn't clear cut as to how to comply with these regulations. First, as with many legal and government documents, it's daunting just to read the regulations click here to read. Secondly, the regulations only outline objectives for a quality system that ensures good manufacturing practices but they don't specify methods that must be used to ensure compliance. In addition, not all of the 21 CFR Part 820 regulations are relevant to the dental laboratory setting. Therefore, it's largely up to the laboratory owner to figure out how to be in compliance. "The more you research, the more confusing it becomes because there is no definitive source that can tell you how to comply," says Lesh.
FDA guidance document
As part of its scrutiny of the industry, the FDA invited NADL representatives to a November 2004 meeting to discuss its concerns about ensuring public safety and its ability to monitor the materials used in foreign imports. "NADL representatives offered an overview of the industry, explained how laboratories operate and their relationships with the dentists, and reviewed the available self-guidance/certification programs such as CDT and CDL programs and DAMAS," writes Bennett Napier, co-executive director of the NADL, on its website, www.nadl.org. "The FDA also asked a number of questions about the industry, many of which were aimed at determining the volume of dental work that is being fabricated offshore and how it's being done."
The FDA is currently in the process of developing a guidance document clarifying its regulations regarding foreign dental laboratory registration requirements, QS/GMP requirements, material traceability issues, labeling and disclosure requirements, specific triggers which require domestic dental laboratory registration and a product code classification.
While some issues are being reviewed, the following regulations were confirmed during the FDA/NADL meeting:
All dental laboratories are subject to compliance with the FDA's Good Manufacturing Practice requirements and Quality System regulations outlined in Title 21 Part 820 of the Code of Federal Regulations.
All foreign dental laboratories shipping into the U.S. and U.S. brokers or agents for foreign dental labs need to register with the FDA.
All domestic and foreign laboratories that fabricate sleep apnea or snoring devices--or any other medical device that is not part of the core dental lab function--must register with the FDA as well as submit 510(k) pre-market forms for the product manufactured.
Laboratories outsourcing domestically do not need to register with the FDA.