Dental Laboratory Industry Piques FDA Interest

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...