Outsourcing manufacturing has led to increased regulatory oversight, but most labs might already be FDA compliant.
How does FDA oversight affect the lab and what does it mean to the clinician? Our web feature this month seeks to clarify the issue and present best practices for clinicians and labs to comply with FDA regulations.
Computer Aided Design and Computer Aided Manufacturing (CAD/CAM) have revolutionized dentistry. Not only has the technology improved the way restorations are designed and created, but it has also increased the speed of delivery the patient. CAD/CAM technology has also made some restorations possible that at one time might have seemed impossible.
Conversely, CAD/CAM dentistry has also created concerns in the FDA about the need for oversight and regulation. Some dental laboratories began receiving FDA compliance letters a couple of years ago, regarding product descriptions on their websites. Many dental professionals and dental technicians wondered what the FDA’s involvement meant for the future of dental labs that use CAD/CAM technology.
What are the FDA regulations for CAD/CAM manufacturing of dental restorations?
It started with the implant abutment. Dental laboratories adjusted implant/abutment interfaces by hand for years without FDA oversigh, and many still do.
Evo820 is a consulting firm that helps dental laboratories who use CAD/CAM technology comply with FDA regulations. Tim Torbenson, President of evo820, says that dental laboratories have been enjoying an exemption from FDA registration and listing requirements under Code of Federal Regulations Title 21. 21 CFR 807.65(i).
As Torbenson explains, the modifications of implant abutments were exempt because everything was done by hand and every lab has their own way of doing things.
“It was a craft and less like device manufacturing, where each device was handmade specifically to accommodate a patient. There was no way for the FDA to regulate that because everyone did it differently,” Torbenson says.
Steve Tapie is the implant manager for Keating Dental Arts Dental Laboratories with 35 years’ experience working in dental labs. He says they modify stock titanium abutments because the companies they work with are already cleared by the FDA, but not with a machine.
“We can alter them a little bit,” Tapie says. “We don’t have a mill we put them in, they are hand-altered.”
However, as more labs milled custom implant abutments with CAD/CAM technology, the FDA began to take a closer look. The FDA wanted to ensure that labs are using mills and materials validated for use with the software and in-lab milling.
Torbenson says that the FDA did not change its stance concerning dental laboratories and the restorations that they manufacture, but that some dental laboratories have moved into a position that now may require more FDA compliance when they advanced and incorporated some of the new technologies.
“The FDA has always been very clear that the abutment that goes into the implant - the implant abutment interface - has always been subject to a 510(k),” Eric Thorn, in-house counsel for the National Association of Dental Laboratories (NADL) says.
According to Thorn, labs began incorporating more CAD/CAM into their implant making back in the early 2010s, which triggered inquiries from the FDA.
Continue to page 2 to read more...
The FDA classifies dental implant abutments as Class II medical devices. A Class II medical device is an object that a healthcare professional uses to diagnose, cure, or treat a patient that affects the structure of the body and poses a moderate to high risk to the patient. Most medical devices are considered Class II medical devices, per BMP Medical, a medical device manufacturer.
The FDA considers dental laboratories that use CAD/CAM to make Class II medical devices as manufacturers. Manufacturers of certain Class II medical devices such as sleep apnea devices and importers have been required to register with the FDA for over twenty years. Moreover, the oversight is not limited to implant abutments made with CAD/CAM - all restorative devices are subject to quality systems regulations, even when made by labs that are otherwise exempt from registration.
Manufacturing of most Class II medical devices requires a 510(K)-pre-market clearance. A 510K is a certificate from the FDA that says what the manufacturer is producing is at least as safe as a similar product already on the market. The cost for a dental laboratory or a 510(k) holder to register a facility with the FDA is $4,884 annually.
In most cases, Torbenson says thata dental laboratory does not need to have its own 510(k) for the restorations they produce. “The exceptions here would be for laboratories that choose to market their own branded sleep devices or orthodontic sequential aligners,” he says.
Most dental implant, and dental implant component companies, hold CAD/CAM 510(k) clearances. If dental laboratories follow what is outlined in the 510(k) and can provide the proper documentation to support it, they will be FDA-compliant without their own 510(k) clearance.
“In meetings with industry groups going back to at least March of 2014,” Thorn wrote in a 2016 article for the Journal of Dental Technology, “FDA’s direction had been that as long as the dental laboratory follows the manufacturer’s specific instructions, and the manufacturer’s specific instructions have been 510(k) cleared by the FDA, a dental laboratory may mill the collar/post for a specific patient pursuant to a dentist’s prescription without the lab having to obtain a separate 510(k) clearance.”
Torbenson says that the documentation is still vital. The FDA regulates CAD/CAM technologies in the dental laboratory under the FDA’s Title 21 CFR 820, which providesa framework for Current Good Manufacturing Practices (CGMP), and quality management procedures used in the manufacturing of Class II medical devices.
Dental laboratories producing dental restorations by hand or with automated manufacturing technologies have always needed a Quality Management System (QMS), which documents internal processes and procedures to demonstrate that the lab follows CGMP and abides by Title 21 CFR 820.
The FDA wants to know that the dental laboratories have a consistent and deliberate process for manufacturing that produces quality devices - and they want to see it in writing.
Evo820 helps dental laboratories by creating a customized QMS specific to the laboratory’s needs. Torbenson says that it will not take much for most labs to become compliant.
“Everything that the FDA is asking us to do or document … are things that we are already doing,” Torbenson says. “So, it’s not a tremendous leap to become FDA compliant. You just have to know how to do it and what to document.”
Continue to page 3 to read more...
How does FDA oversight affect the lab?
So far, the FDA has mostly sent compliance letters to a few dental laboratories that mill implant restorations. As more dental laboratories adopt automated technology and more dental restorations are produced via CAD/CAM, the FDA is changing their approach.
“The FDA has increased its scrutiny of dental laboratories and is looking at industry publication advertisements, internet blogs, and other social media outlets to find laboratories that are manufacturing Class II devices,” Torbenson says. “It is not just those laboratories that are registered with the FDA. They start with a telephone call, but this can lead to an FDA audit if it is deemed that the laboratory is manufacturing these devices.”
Torbenson reports at least two incidents of FDA audits of dental laboratories. The FDA audit is to determine that the lab operates under a QMS and they want to see the documentation that validates it. He describes what a lab could expect in that situation:
“The FDA will inform a facility four to five days prior that the FDA is sending an inspector to perform an audit. They will also inform the dental laboratory of what sections of their Quality Management System that they are going to audit as well as the approximate number of days the audit will take. With that information provided by the FDA, the dental laboratory can begin to prepare for the audit.
“There is a very specific protocol for the audit. The auditor will arrive at the dental laboratory and present a 482-Form that is the formal announcement of the audit. The inspector will then ask to meet the company’s management and the quality representative for an introduction and an opening meeting. Once this is completed the audit will commence, and the inspector will tour the facility and begin to request certain documents to review. Once the audit is completed the FDA inspector will hold a closing meeting and present his/her findings verbally and in a written report.”
The good news is that Torbenson says it is not burdensome or expensive to become an FDA-compliant dental laboratory. The materials, products, and components the lab uses have 510(k) clearances. Moreover, he says most dental laboratories do all that is required by the FDA with only one area that needs improvement: documentation.
“The FDA wants to see documentation that specific procedures and processes are completed properly,” Torbenson explains.
Tapie says Keating Dental Arts is 100 perfect FDA-compliant with documentation for the Keating Custom Abutments, which are CAD/CAM custom-designed titanium abutments. Tapie explains that when Keating Dental Arts buys a part for a case, they make copies of its accompanying documentation to apply to the doctor’s prescription for the patient along with the lot number. Then, they scan the documentation into the Keating Dental Arts system’s records, and the doctor gets a copy for the patient file.
“If the FDA came knocking on our door and checked our records, I am fully confident we would have no issues whatsoever,” Tapie says. “We document everything.”
Also, Tapie says the software serves as another line of defense against using non-compliant materials. For any product they use, if the company isn’t FDA-cleared, then the software will not allow the technician to download the .dne file.
“Even our software protects us,” Tapie says.
Another option for a lab to be FDA-compliant is to outsource milling to a 510(k)-holder facility, which is what Thorn says many labs do. After receiving the digital scan from the doctor, the lab designs the abutment and then sends it out for manufacturing.
“The 510(k) abutment manufacturer has done all the metal fatiguing and all the other tests that need to be done to get a 510(k). The hard stop on that is the 510(k) holder because they won’t mill it outside the design parameters… that’s what makes it acceptable to the FDA,” Thorn explains.
Continue to page 4 to read more...
How dentists can protect themselves and their patients
The FDA does not regulate the practice of dentistry. That means a dentist that produces restorative materials via CAD/CAM in-house for use in the practice on their patients are not subject to FDA oversight. Torbenson says the clinician mostly needs to be aware of the situation regarding dental laboratories and ensure they can trust their lab to be compliant.
“The clinician needs to be aware of these FDA requirements when choosing a partner laboratory and should be working with an FDA compliant dental laboratory for Class II restorations,” Torbenson says.
Thorn agrees that clinicians should work with a reliable partner, preferably one where you have visited the facility and observed how they work. While Thorn says most labs are ethical and follow the rules, the clinician has the duty of diligence because dentists put the implant or other restorations in the patient’s mouth.
Thorn says dentists should ask the following about implants and other dental restorations in today’s global marketplace:
“It’s important that the clinician know where the lab is that made it, what is in it, and the qualifications of the dental lab technicians that fabricated it, so they know they are getting good quality,” Thorn says. “As a dentist, I would want to ensure that my good dental work is not undermined with inferior lab work. That’s a matter of due diligence.”
If a dentist ordes an abutment from a laboratory, Thorn suggests requesting a written document that includes the 510(k) number of the abutment manufacturer, if applicable.
Dental laboratories and clinicians need to work with reputable manufacturers. Thorn cautions labs not to order off the internet based solely on price. Major manufacturers provide documentation of the composition of the materials, and some smaller manufacturers can be fine, too.
“Make sure it’s a good operation with a quality product,” Thorn says, “If any work is coming from overseas, it should be from an FDA-registered foreign manufacturing establishment and you should ask for their FDA registration number and written point of origin and materials content disclosures. Not all the work is suspect; some good work comes from overseas..”
Tapiealso suggests dentists request the FDA-Clearance sheet for the product to ensure that every part of every piece needs to be compliant.
“If they are cleared, the FDA 510(k) clearance sheet should be easily available,” Tapie says. “It doesn’t hurt to ask questions. Especially for something this important for the patient and the liability of the doctor.”
Since standards aren’t always the same all over the world, the first step to ensure you have a manufacturer following the FDA’s rules is to get the documentation that they are an FDA-registered foreign device manufacturer.
“If it were a non-major manufacturer, I would want to make sure that I had been there, seen it, or done something to assure that my good work wasn’t being done with substandard materials,” Thorn says.
The ‘who’ of the equation is also a significant concern. Thorn says a qualified technician should make the end product, preferably a Certified Dental Technician (CDT). If a CDT does not make the restorations, Thorn says it is important that there is a CDT on staff at the lab.
“A CDT on staff shows that someone on the premises attends continuing education courses and is keeping up with new developments in materials and methods. Also, CDTs must pass objective written and practical exams showing they have met an objective standard of skill to do the work,” Thorn says. “These qualifications are significant for a restoration like an implant that is going to be in somebody’s mouth for a long time.”
Continue to page 5 to read more...
The bottom line for clinicians
The bottom line from our experts is that the clinician should do their homework, whether on labs to partner with or any systems they buy to use in-house. Tapie says he has talked with doctors that buy systems for their practice, but can’t use them because the supplier didn’t have all the FDA-clearances they needed.
“Everybody has to keep abreast of the newest and latest things coming out. Also, make sure you research any of the new implant systems and software coming out,” Tapie says.
“Dentists can get documentation if they are asking for it, and they should be asking for it in order to protect their patients,” Thorn says. “It puts the lab on record. If they have a problem, dentists can protect themselves.”
Torbenson says there is much fear in the marketplace that is misplaced. The FDA is not trying to make things difficult or put dental laboratories out of business. They are doing their jobs.
“What’s the Difference Between the FDA Medical Device Classes?” www.bmpmedical.com. 2 February 2018. Web. 17 October 2018. <https://www.bmpmedical.com/blog/whats-difference-fda-medical-device-classes-2/>.
Johnson, Pam. “Under the Microscope: FDA oversight increases as laboratories transition to CAD/CAM production.” evo820.com. Web. 22 October 2018. <https://evo820.com/blogs/under-the-microscope/>.