The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer direct-to-consumer dental products, fall directly under FDA medical device oversight.
The dental laboratory industry has long held the view that dental laboratory operations do not trigger FDA oversight because of a narrow, albeit ill-defined, exemption for certain medical device establishments. As stated in 21 C.F.R. Section 807.65, "[p]ersons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device" – for example, a "dental laboratory … whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device" – are exempt from the medical device registration and listing requirements under 21 C.F.R. Section 807.
The industry has viewed this exemption to shield dental labs from FDA oversight, including quality system requirements and device approval.
FDA's Warning Letter to Reset Technology Corp. (Reset) signifies that at least this dental laboratory's services were in fact not exempt from registration and listing, nor shielded from FDA oversight.
Warning Letter to Reset
FDA found Reset's products both adulterated and misbranded under the U.S. Food, Drug and Cosmetic Act (FDCA). The company's products were adulterated because the manufacturing, packing, storing and instillation of the products were not in compliance with FDA's quality systems and current good manufacturing practices.
Moreover, FDA found Reset's complaint handling and investigation systems and its procedures for implementing corrective and preventive action inadequate. FDA also found the company's ResetSmile Partial Denture and the at-home ResetSmile Impression Kit Devices adulterated because they lacked premarket approval (PMA) or approved applications for an investigational device exemption.
In addition to finding Reset's products adulterated, FDA also found the company's ResetSmile Partial Denture Devices to be misbranded under the FDCA because it failed to timely submit to FDA a report identifying the medical device correction the company took after initiating a correction to remedy dentures that were not performing as intended. FDA also argued Reset's products were misbranded because it had not registered its facility or listed the products it manufactures. FDA stated that exemption under 21 C.F.R. Section 807.65 was not applicable because Reset "manufactures and distributes partial denture devices using devices that lack required approval/clearance and manufactures and distributes impression kits comprised of devices that lack required approval/clearance."
Takeaways and Considerations
Although FDA's Warning Letter is specific to Reset, it could have broad implications if the agency now interprets those provisions in this manner. Other dental laboratories and additional facilities or providers – such as hearing aid dispensers, opticians, clinical laboratories and assemblers of diagnostic X-ray systems, as well as personnel from a hospital, clinic, orthotic or prosthetic retail facility that engage in direct-to-consumer practices or provide a service through the use of previously manufactured devices – should ensure that they are complying with applicable FDA requirements based on their operations and business.
