Below are 3 different methods used by the FDA to deliver information of how they modified requirements and regulations.
- The FDA introduced the new Product Code PZY for the Additively Manufactured, Preformed Resin Denture Tooth. The manufacturing of a 3D printed denture requires a Quality Management System to comply with Code of Federal Regulation 820.
- They added the “note” to an existing Product Code NDP Accessories, Implant, Dental, Endosseous involving printed or milled implant surgical guides. This now requires the dental laboratory to register with the FDA and implement a Quality Management System.
- A requirement was added to the IFU for CAD/CAM manufactured custom abutments in their 510(k) Clearances to use only “Validated Milling Centers” for the manufacturing of the Ti Blank and Ti Base implant supported restorations. These Validated Milling Centers are viewed the same as Contract Manufactures and must register with the FDA and implement a Quality Management System.
We are seeing the “establishment exemption” removed from more CAD/CAM procedures in dental laboratories. Those labs still using the traditional analog handmade methods will always have that exemption. But as an industry, the move to automated manufacturing will require more dental laboratories to register with the FDA, implement a Quality Management System and be open to an FDA audit.
This very event, the FDA audit, that so many dental lab owners fear, is misguided. The FDA does not want to shut down dental laboratories. They recognize the critical role that these medical device manufactures play in each patient’s oral health care.
Our experience with the FDA during 8 audits, has demonstrated that the FDA is looking for ways to help you improve your quality system. As stated by Lab owner Kevin Crane in his May JDT article, “Who’s Afraid of the Big Bad Wolf” demonstrated the FDA investigator was looking to help them understand and improve a Quality System. It is only those labs that are in gross negligence or are simply operating outside the law will have the FDA act to interrupt their laboratory production until they correct their operations. This situation is rare and has just happened with production stoppage due to illegal activity. But please understand, for a lab to become and remain FDA compliant is not that difficult or overly burdensome for CAD/CAM labs.
Instead of fearing the FDA, accept the fact that they are here and not going away. Becoming FDA compliant, a dental laboratory can bring many new manufacturing procedures inhouse, stop outsourcing, gain higher profit margins on the medical devices you provide directly to your dentist clients.
There has been so much misinformation used to instill fear that unnecessarily has kept you staying in the shadows, keeping you from building a bigger and better lab. Build a true CAD/CAM production business and increase revenues by offering a complete line of dental restorations while touting and promoting your FDA compliance.
Grow your laboratory with a clear strategy while complying with the FDA. Instead of outsourcing, incorporate all the CAD/CAM device manufacturing services that are now FDA regulated but not complicated to become FDA Compliant. There are so many more devices covered under a QMS and Establishment Registration that do not require a 510(k).
The critical factor here is to understand the new or modified FDA requirements on some devices. Get to know the FDA’s position.