NADL Meets with U.S. Food and Drug Administration.
On May 1st, a contingent of eight representatives from the dental laboratory industry (appointed by NADL) met with fourteen officials and staff from the U.S. Food and Drug Administration (FDA) at their headquarters in Silver Spring, Maryland.
This meeting was the result of interaction that has taken place between the NADL and FDA since January of this year relative to a number of issues in terms of new technology (materials and equipment), process changes in the industry and enforcement.
The FDA brought personnel from different divisions of the agency to the meeting including key staff from the Office of Device Evaluation; Dental Devices Branch;Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Chief Counsel and Office of Regulatory Affairs and Compliance/Enforcement Division.
Effectively, the FDA is evaluating current aspects of how dental laboratories manufacture dental devices. As the dental laboratory industry evolves in terms of using new materials and equipment, the agencyâs perspective on what elements of federal regulations apply to our constituents is changing.
A number of topics rose to the top in terms of potential FDA action:
The FDA has questions/concerns on what tasks dental laboratories are actually performing related to implant abutments (both the design element and milling). The key concern is what protocols are in place when a dental laboratory can ask an implant manufacturer for an override on built in software thresholds for angulation.
There are a couple of options for FDA to consider. One is to look at whether or not dental laboratories would have to have a pre market 510k approval for conducting such processes or two, provide some specific guidance on how these tasks should be performed. Itâs more likely that a guidance document would be released rather than requiring dental laboratories to seek 510 approval. That would be an expensive proposition for most dental laboratories to undergo and it was mutually agreed that for an industry of our size and make up that this option would be overkill and not necessary.
FDA is reviewing the âbrandedâ products that dental laboratories market to dentists. When a dental laboratory brands a product such as âXYZ Crownâ or âABC nightguardsâ technically, a laboratory should register this product with FDA under its name since by branding it under the laboratoryâs name could be considered that the device is adulterated if the device is manufactured based on a manufacturers 510k market approval.
NADL and FDA held considerable discussion on enforcement both in terms of inspections and un-registered activity or mislabeling. Both parties came to some agreement on the best way for the agency to enforce existing regulations rather than seek additional oversight authority. FDA is interested in exerting its authority on dental laboratories that are not following registration and listing and labeling requirements when they are importing dental restorations.
On another element of enforcement, NADL will be developing some tutorial documents for the FDA so that they can use these resources to assist agency inspectors when they visit dental laboratories so the inspector knows what types of dental devices and processes are present in a laboratory. In many cases, those dental laboratories that have had inspections from FDA in the past, have vastly different experiences. For example, some inspectors go beyond what is required based on a dental laboratory environment, thinking they are a raw material or equipment manufacturer.
In terms of enforcement, NADL stressed that dental offices that have in house laboratories, under the federal regulations are defined in the same manner as a commercial dental laboratory. The fact that a dentist is on site should have no impact, as dental devices are being manufactured in both settings.
NADLâs Board of Directors will be reviewing next steps to best serve its memberâs interests on this important subject. FDA is seeking further input from NADL during the summer so that it can outline an action plan for any future guidance it may deem necessary to publish.
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