Although the FDA has long been actively involved in overseeing the manufacturers of dental laboratory materials, it paid minimal attention to dental laboratories until several years ago, when the rise in imports from overseas laboratories raised a red flag. Concerned that restorations produced outside the U.S. might not contain FDA-registered materials that are legally required to ensure patient safety, the agency began taking a closer look at foreign imports and, consequently, domestic operations.
WHAT YOU NEED TO KNOW:
Good Manufacturing Practices (GMP). In addition to dental materials, the FDA regulates manufacturing processes--but not the final product. A key area of FDA concern is the 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 of all types and sizes.
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 been the last several years that the FDA has begun inspecting U.S. laboratories to ensure compliance.
What has led to confusion is that there is no absolute checklist on how to comply; the regulations outline objectives for a quality system that ensures good manufacturing practices, but they don't specify methods that must be used to ensure compliance. To fit the bill, a number of laboratory owners have implemented comprehensive quality systems like the NADL's Dental Appliance Manufacturers Audit Scheme (DAMAS) or ISO certification.
FDA registration. For the most part, domestic laboratories don't need to register with the FDA. Those who must register include:
- All domestic and foreign laboratories that repackage or relabel material such as porcelain.
- All domestic and foreign labs that fabricate sleep apnea or snoring devices--or any other medical device that is not part of the core dental lab function.
- All foreign dental laboratories shipping into the U.S.
- U.S. brokers or agents for foreign dental laboratories shipping into the U.S.
- All domestic labs that ship directly to and from foreign dental labs without using a registered broker or agent. For most laboratories, there is no fee to register with the FDA.
Labeling requirements. In August 2005, Congress passed the Medical Device User Fee Stabilization Act, making it a requirement for laboratories to identify restorations they distribute but don't manufacture. "For example, if XYZ Dental Lab outsources to either a domestic or foreign laboratory that makes all or part of the restoration, it must indicate 'Manufactured for XYZ Dental Lab' or 'Distributed by XYZ Dental Lab' on its package when it's sent back to the dentist," says Bennett Napier, CAE, co-executive director of the NADL.