Q&A With Laboratory Consultant Chris Brown
Inside Dental Technology Editorial Advisory Board member Chris Brown, BSEE, Manager of Aclivi Consulting, has extensively explored the issue of FDA compliance and gave a lecture on the subject in Chicago this year. He took time to answer IDT’s questions about the recent developments and future compliance issues.
Inside Dental Technology: How would you describe laboratories’ response to the FDA’s increased attention to CAD/CAM milled abutments over the past year? Chris Brown, BSEE: A little bit of fear and a lot of uncertainty.
IDT: Have laboratory owners taken appropriate action?
CB: Most laboratories that are producing all-titanium abutments or hybrids are not truly in compliance with the FDA requirements. Honestly, most of them have an unclear understanding of the requirements, and that is why they are in violation. That being said, I have observed a number of laboratories, particularly the larger ones, researching the situation and starting to take appropriate action to bring their businesses into compliance.
IDT: How would you describe the manufacturers’ response? Which CAM systems currently have FDA clearance for milling implant abutments, and are there other manufacturers of CAM equipment actively seeking FDA clearance?
CB: Some manufacturers are pursuing a very legitimate FDA 510(k) solution for laboratories. Biodenta obtained 510(k) clearance for its abutment system in a way that allows laboratories to use its products to CAD/CAM design and mill implant abutments as FDA-registered Contract Manufacturers. In my judgment, this is a strong solution. The manufacturer is required to sign a manufacturing agreement, implement a Quality Management System (QMS), and validate the calibration and accuracy of the equipment on a regular basis. It is all part of the operational requirements.
Another option is using the system developed by Dentsply Sirona and 3M’s Lava, whereby laboratories buy the equipment but are not responsible for the other controls such as a QMS, 510(k), or registration with the FDA. With this business model, the equipment manufacturers had to validate that their system would remain in compliance with the design controls that were part of their Design History File (DHF) and 510(k) submission. They had to complete a much more in-depth, complex validation of the entire process to prove that it maintains its integrity, accuracy, and connectivity long-term. It is a very in-depth, expensive endeavor on the manufacturer’s part. I do not know of any other company pursuing this path to compliance.
A number of other companies are pursuing and/or expanding upon the precedent set by Biodenta, or exploring other ways to provide the laboratory with the ability to obtain a 510(k) solution of its own. This includes companies that are currently selling machines capable of milling abutments. If these companies follow the contract manufacturing model, there will be a pathway for many of the laboratories that purchased these machines to produce abutments with that equipment.
IDT: What are the benefits and drawbacks to each of these business models?
CB: With the Sirona-Lava method, you are limited to milling only hybrid abutments using those companies’ materials. Neither of those machines mills titanium. The advantage, of course, is that those systems do not require FDA registration or a QMS. The advantage to the Biodenta method is you have a pathway for both all-titanium and hybrid abutments. The downside is you need to register with the FDA and become a Medical Device Manufacturer. You need to implement a QMS, report customer complaints and failures to the FDA, and more. Being an FDA-registered Contract Manufacturer brings on overhead expenses that cannot be ignored. For a one- to three-person laboratory, it could be cost-prohibitive. For a larger laboratory or a milling center, it is very manageable. They can spread out the $4000 registration fee and the QMS implementation and maintenance costs; if they produce more than 500 units per year, then $8-$10 per unit extra cost can be manageable. If a laboratory fabricates 20 abutments per year, incurring those costs would not be what I consider smart business.
IDT: Given that so many machines are advertised as being capable of milling abutments, were some manufacturers caught off guard by this compliance issue?
CB: In terms of suppliers and manufacturers of milling machines, yes, I think they were caught off guard. Honestly, there has not been much clarity up to this point regarding how the FDA is interpreting and enforcing the current guidelines. The FDA says nothing changed and that it has always enforced the regulations this way. What has changed is greater awareness. More people are becoming informed, and for that reason some of the manufacturers were surprised.
Some milling machine manufacturers have been under the impression that using FDA-cleared blanks is sufficient. That is not the case. The FDA considers the laboratories using CAD/CAM to mill those blanks to be Medical Device Manufacturers, and 510(k) clearance is required. That information, although it existed, really was not easily accessible. There still is no clearly defined document showing how the FDA is addressing this issue.
The situation is analogous to our legal system. Laws are passed, and gray areas always exist in those laws. When someone encounters one of those gray areas in a lawsuit or other legal action, a judge considers the law as it was written and makes an interpretation. From that point forward, that interpretation is used as a precedent for any similar gray area in that law. That is what is occurring with the FDA: As they cite people for violations or issue new 510(k) clearances, they are setting a precedent for how the rules are being interpreted. For any future questionable situations, they will point to how it has been handled in the past. Thus, it is unlikely that the FDA will release any documents; instead, they will refer to what they have cleared and what they have cited in order to demonstrate what is necessary to be compliant.
IDT: What developments do you envision over the next year or two, specifically regarding other implant interfaces such as CAM milled bars?
CB: I think we will see more of the major implant companies offering their own solutions. Remember, they already have their own 510(k) clearances. In addition, I think we will see some of the larger laboratories and milling centers handling implant abutment and bar manufacturing under either their own or more likely somebody else’s 510(k) as Contract Manufacturers.
IDT: Do you think laboratories that currently mill implant abutments will revert back to outsourcing this product to avoid FDA issues?
CB: If it makes good business sense for a laboratory to invest in a 510(k)-cleared cleared process and equipment, the laboratory absolutely should. However, laboratories still have the ability to use CAD software to design the abutment and send it to a facility with a 510(k)-cleared solution for milling. That facility will handle design validations, looking at the restrictions for the milling system and ensuring that those restrictions are met before milling the abutment. The onus falls upon the 510(k) facility to ensure that it is staying within the design constraints allowed under the 510(k) and that it is following the FDA’s requirements for reporting and following up on failures, training, equipment calibration, etc. That is the direction I think most low-volume-abutment laboratories should be looking.
IDT: Do you anticipate the FDA becoming more involved in other laboratory procedures in the future?
CB: Nobody knows for sure. I honestly do not believe that the FDA wants to start poking its nose into the 7000 dental laboratories throughout the US. The FDA just does not have the resources. You never know, though. There may be a segment of the industry that gains the FDA’s attention.
If I owned a dental laboratory today, I would be outsourcing the milling of abutments to 510(k)-cleared manufacturers, and keeping an eye on what the FDA is doing in terms of enforcement in other areas. If the FDA starts pursuing laboratories more vigorously, then I would definitely take appropriate action. Honestly, I believe some aspects of Quality Management Systems, such as the documentation of processes, training, maintenance procedures, and tracking customer complaints, would really benefit dental laboratories regardless of whether or not the FDA is involved.