Quality Assurance / FDA Dental Review 2023 and Outlook 2024

As we step into the year 2024, it's important to reflect on the challenges we faced in 2023 and the determination we exhibited alongside our clients. With a brand new year ahead of us, we eagerly anticipate the possibilities it holds and remain dedicated to surpassing the expectations of our valued clients. Let's delve deeper into the notable impacts that FDA dental regulations had in 2023 and what lies ahead for us in 2024.

FDA Dental Regulations Impact 

There were more inspections in 2023 than in prior years from our viewpoint. The significant increase in the number of dental laboratories manufacturing classified devices requires registration with FDA which puts the dental laboratory on FDA’s inventory for an inspection. The FDA’s role is ensuring patient protection so this increase in monitoring compliance is necessary to protect the public.

Looking Ahead on Quality

Quality assurance should be considered a necessity for not only patient protection but also for the liability of the dental laboratory and the dentist. Quality directly affects the bottom line of both dentists and dental labs so why is it so often considered just another one of those government requirements?  The FDA works to protect the public; therefore, a quality management system is required for a dental laboratory to be able to ensure that they have standards in place to produce a quality product that meets the expectations of their dental clients.  

The cost of registration is a consideration that a dental laboratory often is not aware of when it decides to expand into areas that require them to register with FDA. FDA requires certain establishments that import or manufacture medical devices to register with the FDA. The registration fee for FY 2024 (October 1, 2023, through September 30, 2024) is $7,653. There are no waivers or reductions for small establishments, businesses, or groups in FY 2024 according to the information published by the FDA. This registration must be paid annually so a cost that needs to be calculated into the cost of working under that type of business model.  

Registering with FDA also places the registered establishment into the inspection inventory for FDA. From SafeLink Consulting’s experience in 2023 and reports from the NADL (National Association of Dental Laboratories) during last year, FDA inspections of dental laboratories have significantly increased. Inspections are typically based on the type of registration so ensuring that an establishment is registered correctly is critical. The next critical factor is the development and implementation of an appropriate Quality Management System.  Learn more about FDA quality system regulation here.

The inspections that SafeLink Consulting has participated in have indicated a real need for a good document control system as well as methods in place that document the standards that are in place and that they are being followed. Also, the plan by FDA to adopt ISO 13485 as the format for a quality management system, caused SafeLink to search out and strategically align with Grand Avenue Software. This eQMS software will help companies achieve compliance quickly, standardize processes, increase productivity, control overhead expenses, and ultimately increase profit. When facing an FDA inspection, a dental laboratory needs to be able to quickly produce the evidence that the FDA inspector asks for and be able to show that standards are being followed. 

What are your business plans for 2024?

Your first step should be to ensure that your management team has access to a knowledgeable resource on the regulations that apply to your business. Contracting with an expert such as SafeLink Consulting is a step in the right direction.  Contact us to learn how services are utilized to benefit your business to assist you in achieving a more successful and prosperous 2024!  Learn more about SafeLink's year in review.