Tonight, we will be focusing on the United States Food and Drug Administration (FDA). I will answer the following questions; Why now? Who is affected? What will you have to do to comply?
Overwhelmingly the largest contributor for the new attention that dental laboratories are getting from the FDA is due to the increase in import trade.
FDA is focusing on the materials and procedures because they both relate to patient safety and long-term health.
Class I Medical Devices are usually thought of as more common and do not require FDA testing and study before they are introduced to the U.S. market. Class II Medical Devices, such as sleep apnea appliances and some orthodontic appliances require testing and research by the FDA before they become “approved for the market”. We will discuss how manufacturing and distributing a Class II device requires registration with the FDA. Class III medical devices…..
So I already told you that the number one reason that the FDA is taking a closer look at dental laboratories is the increase in import trade. Additionally, it is because the U.S. enacted some laws to protect it’s citizens by making imports have to meet FDA guidelines.
To give you a quick overview of when and how the FDAs activities began to catch the eye of the staff and leadership at NADL. In 2003 the FDA released three guidance documents relative to Class II Medical Devices. Additionally, in July of 2003 a dental laboratory in Costa Rica was inspected for QS/GMP – this laboratory was owned by a laboratory that was based in the U.S. Additionally, between August 1, and December 17, 2003 a lot of other activity took place. Specifically, in August, September and again in December three different shipments containing dental restorations were stopped at port for disclosure requirements (510K). These restorations came from Pakistan, China and Asia. Additionally, two U.S. based laboratories; and ortho lab in Texas and another lab in FL also received warning letters from the FDA on non-compliance with FDA’s QS/GMP. Last an Alberta, Canada based dental lab that does work in the U.S. was inspected by the FDA for QS/GMP compliance.
At the end of 2003 NADL staff begin to actively monitor the FDA activities relative to dental laboratories. Although we have little data to compare it with, it appears that the activity has increased significantly. Between January and the end of July2004, five shipments have been held at port for 510k disclosure requirements. Perhaps more concerning to NADL is that 2 additional U.S. based laboratories, one in N.J. and one in Texas were sighted for inspection by FDA for QS/GMP compliance.
There are three primary reasons that a dental laboratory would have to register with the FDA: (1) All foreign dental laboratories must register. (2) Domestic laboratories that are “initial importers” must register; and (3) Domestic laboratories that manufacture Class II Medical Devices (sleep apnea and some orthodontic appliances). Regardless of whether or not your laboratory is required to register with the FDA or not, all dental laboratories fall under the oversight of the FDA and are therefore subject to inspection. Foreign dental laboratories must register so that the FDA can track who is shipping into the U.S. – foreign labs are subject to FDA inspection. Domestic labs that import dental prosteses from a foreign laboratory – again so that FDA can track both the original manufacturer and materials and products. And labs that produce Class II devices such as sleep apnea/snoring appliances because the design and use of these devices is regulated and strictly enforced by the FDA.
To ensure that the FDA is notified of all regulated products imported into the U.S., the importer, or their representative, must file and entry notice and an entry bond with the U.S. Customs Service pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with U.S. Customs with whom FDA has an excellent working relationship.
Unless a domestic dental laboratory meets one of the requirements outlined, then they are exempt from registering with the FDA.
Many laboratories outsource work to another laboratory – some within the U.S. and some outside the U.S. Domestic-to-domestic outsourcing is pretty common. Many laboratories have found that outsourcing to another laboratory can be profitable and can save a laboratory time and the hassle of investing in additional equipment. Record keeping is the key.
Regulation of Advertising and Marketing FDA prohibits “misbranding” of devices, including: false or misleading labeling; “including proper disclosure language” such as “manufactured by or distributed by” failure to include required information (brief statement of intended uses and warnings, precautions, side effects and contraindications) If the laboratory delivers the restoration in a box marked with only the laboratory’s name and does not include either the “manufactured by” or “distributed by” language then the dentist assumes that the delivering laboratory was the producer of the restoration and therefore is mislead. This is a violation of the FDA regulations.
Although domestic-to-domestic outsourcing is still the most common practice, it is still important that you protect your laboratory by following a few simple practices.
Ignorance of the law is not an acceptable excuse fro non-compliance. For most dental laboratories, compliance will not be a burden. Compliance is a simple matter of continuing the quality practices in which you likely already do, but adding a step by documenting them appropriately.
Manufacturers must comply with current good manufacturing practices, which is the quality systems regulations. These regulations are applicable to all manufacturers of finished devices. If a manufacturer engages in only some of the activities regulated by GMP/QSR, then they only need to comply with those regulations. Dental laboratories are limited in the scope of what we need to comply with under 21 CFR (Code of Federal Regulations) 820.