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Want to become 510K compliant with teh FDA?
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<blockquote data-quote="Tim Torbenson" data-source="post: 256083" data-attributes="member: 19412"><p>The question is not who is making the restoration, the question is are they selling the restoration outside of their business? An in house dental lab is not a commercial lab and as such, in today's regulatory environment, is exempt. This may change in the future as the FDA continues to provide more oversight in the dental laboratory segment. The same would be true for the dental technology schools.</p><p></p><p>This is not a 510(k) clearance issue, it is compliance with Title 21 CFR 820 of the FDA GMP guidance. Below is a portion of a newsletter on the topic:</p><p><span style="font-size: 22px"><strong>Why is the FDA Looking at dental laboratories?</strong></span></p><p> In the past, most dental laboratories have been able to avoid significant FDA scrutiny due to the hand-crafted nature of each case. For years dental technicians have used hand instruments to create wax patterns, brushes to stack porcelain and hand pieces to grind in contours and anatomy without any real ability to regulate, control or accurately document the process.</p><p></p><p>Without the ability of the laboratory industry to establish and follow structured processes in heavily-custom manual operations, the FDA’s main regulatory focus has been the materials used in the dental laboratory.</p><p></p><p>As our industry moved to CAD/CAM (Computer-Aided Design / Computer Aided Manufacturing) processes such as milling and 3D printing, dental laboratory production has moved from manual operations to more true automated and controlled manufacturing operations. When manufacturing operations are used to produce medical devices and those devices are marketed for sale, the FDA has an obligation to make sure device manufacturers are following appropriate protocols in the design and manufacture of their devices. Those protocols are also known as Medical Device Good Manufacturing Practices. (FDA 21 CFR 820 <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/" target="_blank">https://www.fda.gov/</a>) Any manufacture of medical devices must be compliant with the Title 21 CFR 820 regulation.</p></blockquote><p></p>
[QUOTE="Tim Torbenson, post: 256083, member: 19412"] The question is not who is making the restoration, the question is are they selling the restoration outside of their business? An in house dental lab is not a commercial lab and as such, in today's regulatory environment, is exempt. This may change in the future as the FDA continues to provide more oversight in the dental laboratory segment. The same would be true for the dental technology schools. This is not a 510(k) clearance issue, it is compliance with Title 21 CFR 820 of the FDA GMP guidance. Below is a portion of a newsletter on the topic: [SIZE=6][B]Why is the FDA Looking at dental laboratories?[/B][/SIZE] In the past, most dental laboratories have been able to avoid significant FDA scrutiny due to the hand-crafted nature of each case. For years dental technicians have used hand instruments to create wax patterns, brushes to stack porcelain and hand pieces to grind in contours and anatomy without any real ability to regulate, control or accurately document the process. Without the ability of the laboratory industry to establish and follow structured processes in heavily-custom manual operations, the FDA’s main regulatory focus has been the materials used in the dental laboratory. As our industry moved to CAD/CAM (Computer-Aided Design / Computer Aided Manufacturing) processes such as milling and 3D printing, dental laboratory production has moved from manual operations to more true automated and controlled manufacturing operations. When manufacturing operations are used to produce medical devices and those devices are marketed for sale, the FDA has an obligation to make sure device manufacturers are following appropriate protocols in the design and manufacture of their devices. Those protocols are also known as Medical Device Good Manufacturing Practices. (FDA 21 CFR 820 [URL='https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/']https://www.fda.gov/[/URL]) Any manufacture of medical devices must be compliant with the Title 21 CFR 820 regulation. [/QUOTE]
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