NADL Meets with FDA Officials
By NADL Co-Executive Director Bennett Napier
In response to an invitation from the Food and Drug Administration, David Bloch, FDA legal expert, David Evans, NADL general counsel, and I participated in a formal meeting with representatives of the Center for Devices and Radiological Health at their offices in Rockville, Md.
FDA's interest in meeting with NADL and in drafting a guidance document are related solely to FDA's concern over the dramatic increase in imports from foreign laboratories and its belief that this trend will continue. They do not know what materials are being used in restorations made in China, Mexico and other countries. Based on its understanding that the prices foreign laboratories are charging are very low, FDA is concerned that the materials being used may not be FDA approved.
FDA has no interest in expanding its reach over domestic laboratories. It is trying to interpret and enforce its regulations that relate to the importation of restorations.
FDA regulates the dental industry differently than all other industries: it regulates the materials, not the products.
The FDA wants NADL's help to spread the message about what FDA policy actually is in this area to avoid delays and detentions for lack of 510Ks. FDA understands the need for a quick turnaround so the patient gets the restoration in a timely manner. The guidance document is on a fast track to assure the word gets out soon. Evidence of this fast track is FDA's development of new product codes. FDA said it needs the means to police foreign imports to protect consumers.
FDA officials worry that 20 years from now, patients may have leaching from their mouths from materials used by foreign laboratories. They do not have this concern about domestic laboratories. FDA noted, however, that they do not get many complaints from patients or others about problems with restorations.
FDA is interested in getting information out on labeling requirements. They raised the question of how much labeling should there be. They are not referring to customs, country of origin labeling, but rather labeling using FDA forms. They asked if the dentist knows when their domestic laboratory has subcontracted to a foreign laboratory.
FDA will issue a guidance document early next year and hopes that the NADL will submit comments to assure FDA has a good document.
Industry Overview
At the meeting, I provided an overview of the domestic dental laboratory industry which included statistics on total annual sales in the industry; description of the typical size dental laboratory; a listing of the states where statutes require either registration or employment of certified dental technicians in order to operate; a review of OSHA blood borne pathogen standards that dental laboratories are accustomed to following; a description of the typical business model for dental laboratory operation (relative to receiving a prescription from a licensed dentist and subsequent production) and the close customer relationship/partnership that dental laboratories and dental clients maintain.
Additionally, a review of the industry's self-guidance/certification processes were covered including the Certified Dental Technician program, the Certified Dental Laboratory program and the Dental Appliance Manufacturers Audit Scheme (DAMAS) process; and industry developed competency standards. NADL provided hard copy materials of the CDT program requirements, a DAMAS manual including specifications, competency standards and a copy of A Golden Quarter Century the industry report prepared by Peter Stein in 2001 to the FDA representatives.
The DAMAS process was discussed including how closely the specification standards mirror specific elements of the FDA QS/GMP requirements including material traceability requirements.
FDA staff asked a number of good questions about the (CDT and CDL) certification processes as well as the DAMAS quality assurance system. It appears that their staff is very favorable to the industry's ability to provide such programs and that DAMAS specifically requires a third party audit for compliance on manufacturing processes.
FDA Regulatory Concerns and Clarification
The FDA's increased interest of late in the dental laboratory industry is due to the increase of import trade (restorations) coming into port around the U.S. and it's concern about what materials are used in the restorations and whether they are FDA approved materials. Additionally, FDA shared that they continue to field a number of questions relative to laboratories that manufacture sleep apnea/snoring devices and whether or not that triggers registration.
With that said, a number of topics were covered on existing regulations by the FDA representatives:
1. It was confirmed that all foreign dental laboratories need to register with the FDA.
2. It was confirmed that U.S. brokers or agents for foreign dental laboratories need to register with the FDA.
3. It was confirmed that dental laboratories (including domestic laboratories) that manufacture sleep apnea or snoring devices - or any other medical device that is not part of the core dental lab function must register with the FDA as well as submit 510K premarket forms for the product manufactured.
4. It was confirmed that all dental laboratories (foreign and domestic), including those registered and those exempt from registration, are subject to compliance with the FDA's QS/GMP requirements.
5. It was confirmed that domestic-to-domestic outsourcing does not trigger registration with the FDA, nor is it likely to be a concern of the FDA's in the future. This is a very significant determination as a different reading would have affected a vast majority of domestic dental laboratories.
6. It was confirmed that FDA is not seeking to expand regulatory oversight over the industry only to clarify existing regulations and provide more outreach/educational information to the industry on current compliance issues.
7. It was confirmed that FDA generally only will inspect a registered or unregistered dental laboratory for cause and that random inspections without necessity are unlikely.
The FDA representatives shared that a guidance document which is currently in development on the dental laboratory industry would be released sometime in the first quarter of 2005 and will likely cover the following issues: foreign dental laboratory registration requirements; QS/GMP requirements; material traceability issues; labeling and disclosure requirements; specific triggers which require domestic dental laboratory registration; and a product code classification for dental devices in the laboratory setting.
It appears that only one guidance document is forthcoming and that release of such document is not part of a bigger picture/more far reaching effort of the FDA to oversee dental laboratories beyond the issues addressed above.
One of the most significant concerns for the FDA is the ability to trace the materials used in dental devices coming in from overseas. It is very difficult to determine if the restorations used in import shipments utilized FDA approved materials. NADL representatives referred to requirements in the DAMAS process, which require laboratories to have affidavits from third party suppliers (including outsource partners) on material content. FDA expressed comfort with the affidavit/certification process, but requested NADL's assistance in developing additional safeguards.
NADL representatives reviewed the Identalloy program that is in place with a number of dental manufacturers, which provides a tags/stickers of material content disclosure back to the dental client. The FDA representatives received this positively.
FDA asked a number of questions related to the industry, however, NADL did not respond with specifics to the following questions (due to lack of valid data or ability to confirm specifics):
1. How many dental laboratories in the U.S. are strictly pass-through/broker laboratories for foreign establishments? How are such establishments marketing their services to the dental community?
2. What is the percentage of the (sales volume, number of units) marketplace that is being filled by foreign dental laboratories?
3. What is the percentage of the U.S. domestic dental laboratory market that is outsourcing certain elements of the manufacturing process to foreign dental laboratories?
4. What percentage of U.S. based dentists is going direct to foreign dental laboratories for restorative work?
5. Are dental laboratories that outsource production elements to a foreign dental laboratory or broker dental laboratories disclosing to dental clients that such work is being done in a foreign establishment?
6. Can the industry determine some viable business processes in addition to DAMAS and Identalloy whereby material content could be audited/verified when using/working with foreign dental laboratories?
7. What percentage of the U.S. domestic dental laboratories that do work with foreign dental laboratories are shipping the raw dental materials to foreign laboratory outsource partners?
FDA seeks assistance from the NADL through surveys the association could disseminate to answer some of the above questions.
The FDA will be sending two representatives (one from the Office of Device Evaluation and one from the Office of Compliance) to participate at a seminar at Vision 21 West in Las Vegas in January 2005. Although the formal FDA guidance document will likely not be released by this meeting, the panel session would serve as a prequel to the guidance document and give the opportunity for dental laboratory owners/attendees to ask direct questions to FDA officials.
To register for NADL Vision 21 West, go to www.nadl.org/Vision21W.shtml.
For additional information about FDA, click on the links below:
FDA Regulations:
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