Manufacturing Orthodontic Aligners Intelligently

Did you know that sequential aligners are regulated as Class II medical devices in the US, requiring compliance to FDA regulations? This means that if your laboratory is manufacturing and marketing aligners, it must adhere to regulatory requirements or risk action from the FDA.

As a dental laboratory operator, you are responsible for staying on top of the regulatory landscape, but it can be difficult to uncover all of the complex layers involved in navigating the FDA's requirements. This is not because of a lack of intelligence, but rather a lack of regulatory intelligence. It is possible to educate yourself on the requirements, but you need to know how to best interpret these regulations and standards for your dental laboratory and the specific appliances and devices that you are manufacturing, particularly those sequential aligners. Regulatory knowledge comes from experience in the medical device industry and the ability to translate this experience for each specific manufacturer or dental laboratory. It means devising your dental laboratory's regulatory strategy and seeing it through to completion and beyond-intelligently.

Since the FDA regulates dental devices (including aligners) manufactured by dental laboratories the same as it regulates all other medical devices, the FDA requires laboratories to implement and maintain a quality management system (QMS) that is compliant with 21 CFR Part 820. This regulation outlines the specific requirements of a quality system, which are known as current good manufacturing practices (CGMPs). A QMS is a formalized business practice that defines management responsibilities for organizational structure, processes, procedures, and resources needed to meet product requirements, customer satisfaction, and continual improvement goals. When developing and implementing a QMS, the laboratory leaders must use good judgment in developing the system and ensure that the system is applicable to the laboratory.

Not only can a QMS maintain compliance with FDA regulations, but a successful quality system will also be a daily benefit to your dental laboratory. A functional quality system can create operational excellence within your laboratory and give you a competitive advantage by minimizing mistakes, reducing laboratory downtime, and increasing customer satisfaction. A QMS will not only improve the day-to-day operation of your dental laboratory, but it can also improve the quality of the products you are delivering to your customers.

A 510(k) is a premarket submission made to the FDA to demonstrate the device is at least as safe, effective, and substantially equivalent to an already legally marketed device known as a predicate device.  It is through this 510(k) system that the FDA assures that medical devices available in the United States are safe for human use. Each maker of aligners is required to register with the FDA as a manufacturer, and each laboratory must submit a 510(k) application for the aligners. The aligners must be added to the device listings for your laboratory that require a 510(k) designation prior to marketing, which include implant abutments, anti-snoring devices, orthodontic software, and sleep apnea appliances.

There are various types of 510(k) submissions to the FDA, and each has unique requirements. Navigating through these requirements can become daunting for a dental laboratory that is unfamiliar with these processes and regulations. In addition to having regulatory knowledge, it is important to know how to use that knowledge strategically.

In order to achieve all of this in a timely and cost-effective way, a regulatory strategy must be in place early in the process. Knowledge and experience working with regulatory bodies can help predict and effectively recover from any pitfalls. Understanding regulatory paths and their associated risks is key in planning your strategy.

Just like most wouldn't dream of representing themselves in court having only read a few law books, many laboratories would rather not navigate the regulatory waters alone. They can partner with an experienced regulatory and quality consultant who can gauge their unique requirements and act as a liaison with the agencies. Since the requirements constantly change, an expert can help identify changes, assess them based on each facility, and implement them.

All dental laboratory operators, regulatory professionals, and government agencies have a common goal: to allow doctors, dentists, and patients access to safe and effective products. Each laboratory just needs to make sure it is done intelligently.

Scott Wright is the owner of A WRIGHT PATH, INC., in Moon Township, PA.