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Home » Maker of orthodontic planning software snares FDA warning for software validation lapse
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Maker of orthodontic planning software snares FDA warning for software validation lapse

June 28, 2023
By Mark McCarty
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
BioWorld MedTech Regulatory Software U.S. FDA

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