Regulatory Compliance for the Dental Laboratory

FDA Compliance for the Dental Laboratory

The U.S. Food and Drug Administration (FDA) regulates dental laboratories. FDA has a right to inspect dental labs. If your dental lab meets the criteria in the FDA Title 21 requirement, then your business must comply with this requirement.

FDA’s Title 21 requirement

Domestic or foreign manufacturers of medical devices are required by FDA to have “a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.  The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with GMP requirements in the QS regulation.”

Who must register with FDA?

There are many activities performed by dental laboratories that trigger registration with FDA. A SafeLink consultant can help you with making this determination.

What You Need to Know about Dental Laboratory FDA Compliance:

• FDA regulates dental laboratories
• Dental labs that outsource to foreign labs must register with FDA
• FDA has a right to inspect all dental labs
• All dental labs should have a documented quality system
• CAPA (Corrective Action) is required and helps you reduce remakes
• If you manufacture sleep apnea devices or anti-snoring devices, then you must register with FDA
• A contract manufacturer must register and pay an annual fee to FDA
• You must formally evaluate your vendors and subcontractors for compliance to regulatory requirements
• You must be able to trace your patient contact materials in the event of recall
• You must conduct an internal audit of your quality system at least annually
• You must document all complaints from dental clients
• You must implement an effective corrective action process for complaints
• You must comply with FDA to become DAMAS certified

Learn more FAQ’s about dental lab quality systems / FDA compliance.

Quality Management Systems (QMS)

Whether your business needs a fundamental Quality Management System to meet FDA compliance or desires a more comprehensive QMS to improve your overall business model, SafeLink Consulting is ready to help. Hiring SafeLink to assist your business is the most beneficial method of developing your Quality Management System.

Benefits of a Dental Lab Quality System: https://info.safelinkconsulting.com/blog/dental_lab_quality_management_system_certification

How SafeLink Consulting can assist your dental lab with FDA compliance:

• Product-Focused QMS
  Developing a Quality System for a certain product you are manufacturing? This Product-Focused Quality Management System (QMS) is designed to assist you in development of a Quality System that follows FDA’s Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality System Regulation and any other FDA regulations applicable to your desired scope. Includes: onsite or virtual consulting, electronic Quality System documentation, assistance with FDA communication, educational online training courses, quality topic news relevant to the dental lab, and an onsite internal audit.

• All-Encompassing QMS
  Exploring more ways to improve your business? This Quality Management System (QMS) is designed for the lab that desires an extensive QMS which goes beyond simply FDA compliance. The goal of this QMS is to improve your overall business model for productivity, efficiency and profitability by minimizing errors. A well-structured quality system provides methods for determining the root cause of complaints and reducing reworks/remakes. Ultimately, it will improve your business. This QMS also follows FDA’s Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality System Regulation and any other FDA regulations applicable to your business model. Includes: onsite or virtual consulting, electronic Quality System documentation, assistance with FDA communication, educational online training courses, quality topic news relevant to the dental lab, and onsite internal audit.

• UQ System: Cloud-based Quality Manual
  This Cloud-based application is designed for implementing and managing a quality system online. It reduces paper and the likelihood of a lost quality manual. UQ offers better organization of all documents, plus links policies, procedures and forms. It increases efficiency and provides an audit trail, simplifying a potentially complex issue. UQ allows for tracking non-conformance to improve quality. It can also manage your health & safety manual.

• DIY Quality System for the Dental Lab
  This Do-It-Yourself is an affordable way for the dental lab to develop its own Quality System to comply with FDA’s Quality System/Good Manufacturing Practices requirements. Customizing and printing your own dental lab-specific Quality Manual is simple with easy-to-follow instructions, evaluation tools, sample forms, and standard operating procedures. This DIY is easy to use, self-directed and self-paced. It is sent in a downloadable, electronic/softcopy format.

• Quality System Internal Audit
  Need an Internal Audit to meet the FDA requirements? SafeLink can perform this audit for you to establish conformance with the FDA Quality System Regulation. FDA requires that establishments periodically perform an Internal Audit.

• Quality Connection
  This subscription assists with your existing quality system, an FDA inspection/response if needed, or other quality issue. Includes consulting when needed, FDA assistance, online educational training courses, and quality news pertinent to your business.

• Quality Consulting
  Already have a quality system in place or considering implementing one and have some specific questions about your business? Contact us for quality guidance or assistance with an FDA inspection/response. Hourly consulting available.

• FDA Registration
  Businesses that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. SafeLink can help you determine if your business is required to register and guide you through the process.

• 510(k) Submission Guidance
  Dental laboratories may need to submit to FDA a Premarket Notification, more commonly referred to as a 510(k), for products that are required to show safety and efficacy prior to placing them on the market. This can include intraoral sleep appliances, sequential aligners, TMJ and Bruxism splints, and customized in-house milled implant abutments. SafeLink Consulting can assist you in determining if your business model meets this requirement and provide guidance.