Dancing with the FDA
Dancing with the FDA
If anyone missed the Vision 21 meeting in Las Vegas, here is a brief synopsis: Another very good meeting. Speakers, panels and topics that prepared us for the changes we are and will face in laboratory technology.
One item stood out for me. So much so, that a few days later I filmed another NADL Update with Bennett in the NLN studios in Dallas. The topic; Best Practices Recommendations Response, to the FDA Interagency Task Force. Because of the increasing concern and maloccurences of import and domestic safety issues across a wide range of materials, products and supplies, the FDA has asked the NADL to outline what it would suggest to safeguard consumers and patients as it relates to the profession of dental technology. It is really not a question of if there will someday be an untoward event in dentistry that would necessitate these guidelines and regulations be in place, rather when. It is likely it has already happened and may not have been discovered or reported. We must stand up and be the voice for our laboratory profession. The voice of what is best and right for us and for the patients we ultimately serve.
The 7 key points addressed by NADL are:
1) The FDA should expand its regulatory interpretation of "qualified to place a product on the market" to include a reference to the Certified Dental Technician designation when speaking about the manufacture of dental devices, whether the product is foreign or domestic. In this sense, a best practice would be to have one CDT in each laboratory. This is in line with NADL's model bill for state legislation.
2) The FDA should remove the exemption of U.S. dentists from having to comply with QS/GMP regulations which includes labeling and disclosure. There are U.S. dentists and dental schools that are directly purchasing their dental laboratory work from foreign dental laboratories and there is no current requirement for them to comply with the same requirements that a U.S. dental laboratory has to do in the same scenario. This scenario leaves a void in transparency and traceability for product recalls.
3) The FDA should grant approval of the dental Appliance Manufacturers Audit Scheme (DAMAS) to be an approved third party verification/inspection mechanism as it relates to FDA inspection. This would allow DAMAS accredited dental laboratories to be exempt from FDA inspection.
4) The FDA should review the voluntary material content disclosure program for dental devices, Identalloy and IdentCeram for compliance for labeling elements for CFR 820, web link:
5) The FDA should consider requiring all dental laboratories, both foreign and domestic to register either with the FDA, or encourage such requirement of registration through appropriate agencies at the individual state level in state dental practice acts, which generally would be with a state department of health.
6) The FDA should conclude that the end user for dental devices is the patient, not the prescribing dentist, and as such, the point of origin of manufacture of where a dental restoration was created should accessible to the individual patient. It is a consumer's right to know where their dental device was manufactured and what materials are in their mouth.
7) Dentists should be required to include the registration number of their contracting dental laboratory on the prescription that is kept in the patient's record. Such registration information could be the FDA registration number or state specific registration number (in those states where required) for the dental laboratory.
For more information and the full documents go to: Protecting American Consumers Every Step of the Way: A strategic framework for continual improvement in import safety http://www.importsafety.gov/report/report.pdf and http://www.importsafety.gov/report/actionplan.pdf
