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Historically, the FDA—long involved in overseeing the manufacturers of dental laboratory materials—paid minimal attention to dental laboratories. In 2004, due to the dramatic rise in imports from overseas laboratories, that changed. Concerned that these restorations might not contain FDA-approved materials, the FDA started taking a closer look at foreign laboratories and consequently, the domestic operations that imported cases from them. Several laboratories reported random inspections and, later that year, the FDA invited the NADL to a meeting to discuss its concerns about public safety.
The FDA’s involvement in the industry continues to grow, with an emphasis on compliance with its 1997 Good Manufacturing Practices (GMPs) and adherence to its requirements for registration for offshore laboratories, importers, manufacturers of sleep apnea devices and snore guards, and repackaging or relabeling of Class II devices.
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