A Great Article

[Travis]

By Arlene Furlong
San Francisco—Many traditional products found in dental operatories in the U.S. are manufactured outside of its borders.
Resolution 6H-2007 seeks to find a way to notify dentists in advance when prostheses, components or materials indicated in the dentist's prescription are to be manufactured or provided, either partially or entirely, by a foreign dental laboratory or any ancillary domestic dental laboratory.
The resolution amends the Statement on Prosthetic Care and Dental Laboratories by adding the following new language before Glossary of Terms Related to Dental Laboratories in the Laboratory/Technician section:
"Notification of Prosthetic Cases Sent to Foreign or Ancillary Domestic Labs for Custom Manufacture: Constituent dental societies are urged to pursue legislation or voluntary agreements to require that a domestic dental laboratory which subcontracts the manufacture of dental prostheses notify the dentist in advance when such prostheses, components or materials indicated in the dentist's prescription are to be manufactured or provided, either partially or entirely, by a foreign dental laboratory or any domestic ancillary dental laboratory."
The state approach is consistent with current ADA policy on laboratory regulation and offers many advantages such as expediency and ability to create state-specific policy based on impact on members, including determining if the regulation should be voluntary or mandatory. One state, Missouri, offers its members a downloadable advance disclosure form on its Web site.
The National Association of Dental Laboratories believes that voluntary regulation will not be effective because there will be no means of enforcement. Rather, the NADL advocates that each state regulate dental labs through registration and/or certification of laboratories, laboratory technicians or both.
Dentists may not always be making the choice they think they're making when contracting dental laboratory services. Whereas the Food and Drug Administration has the legislative authority to regulate medical (including dental) devices through the Food, Drug and Cosmetic Act, the FDA does not require the registration of dentists or dental laboratories with respect to a dental prosthesis. Only the materials used are regulated and it is assumed by the FDA that only FDA materials will be used in the manufacture of prostheses. The FDA does regulate dental prostheses, by function, as follows:

• Registration. If a device is imported from overseas, the FDA requires the foreign exporter to register. The U.S. agent accepting the prosthesis is also required to register.
• Labeling. Current FDA regulations require that if a foreign dental laboratory fabricates a case, the laboratory must either label the case as "Manufactured for (name of lab contracting with dentist)" or "Distributed by (name of lab contracting with dentist)." This means that dentists do not know prior to delivery where a case will be fabricated or the origin of the materials. Upon delivery of the case, the dentist would need to note the "manufactured by" or "distributed by" label on the case and understand its significance. Some dentists may wish to have this information prior to selecting a dental laboratory.
• Materials. As part of importation, the manufacturer must certify that only FDA-approved materials are used. Actual enforcement of this requirement is done by the U.S. Customs and Border Protection in coordination with the FDA.

Although both the federal and state approaches were considered as means to address the advanced disclosure of subcontracting of dental prostheses to a foreign laboratory, the FDA does not believe it has the authority to regulate dental labs as suggested by Res. 69H-2006; therefore, pursuing a legislative change to the Food, Drug and Cosmetic Act would be required. The federal approach would require the support of the U.S. Congress to change federal law to give the FDA regulatory authority over dental laboratories that it does not currently have (nor want or support), would be a very long-term process and could impact both dentists and dental laboratories in unanticipated ways.
Additionally, the federal approach could be considered in conflict with ADA policy that says: "The Association opposes the creation of additional regulatory boards to oversee dental care and therefore, opposes any form of governmental regulation or licensure of dental laboratories not promulgated under the auspices of the state board of dentistry."

Posted Nov. 13, 2007
Source
ADA.org: ADA News: Dental lab issues considered