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What is the benefit of FDA regulation of dental laboratories?


None of us truly like the government telling us how to run our business. However, put yourself in the position of being a consumer and not having some authority controlling what is safe to put into your body. The FDA should then become important to you. When the FDA began inspecting dental laboratories around 2003, the industry was taken by surprise to learn that the FDA regulated the industry. Since that time, organizations that have taken the steps to comply with FDA’s Quality System Regulation are realizing the benefits of good manufacturing practices. Unfortunately, in 2003 there was no recognized standard that dental laboratories could use as a guideline, but today the NADL offers certification through the Dental Appliance Manufacturers Audit System (DAMAS).

DAMAS provides a method for compliance with FDA’s Quality System Regulation. This is currently the most recognized certification system in place in the US for dental laboratories. Having a third-party audit your system is even greater evidence that you are employing competent workers, maintaining your equipment, and using only FDA registered patient contact materials.

The components of QS/GMP’s include:

  • Determination of applicability and FDA registration
  • Assignment of management responsibility
  • Competency and training of personnel
  • Defining of purchasing controls
  • Identification and traceability of patient contact materials
  • Production and process controls
  • Acceptance of final product
  • Review of Non-conforming product
  • Corrective and Prevention Action procedures for complaints
  • Control of Labeling and Packaging
  • Handling, Storage, Distribution and Installation of materials and finished items
  • Records retention and control

Organizations must determine which parts apply to them and then develop a quality system to incorporate those components.

Our clients who have developed this formal quality system are seeing results every day by having standards on which to base their customer service and production processes. How do you know how well you’re doing if you don’t measure customer satisfaction through a good quality system? Many of you have case management systems that will provide you with reports that you can use to evaluate your remakes, internal reworks, and complaints. Without a good quality system that requires to evaluate its effectiveness at least annually, how are you using all our records to improve your business? A quality system will help you improve your service and your product so this is definitely a regulation that will help you improve your business and put more to the bottom line.


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