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Zdrowie i gospodarka · 22.04.2003

Guidance for Industry and FDA; Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA." This guidance document describes a means by which optical impression systems for the computer assisted design and manufacturing CAD/CAM of dental restorations may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to exempt the type device from premarket notification requirements and establish this guidance document as the special control for the type device. This guidance document is immediately in effect as the special control for optical impression systems for CAD/CAM, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Source: Federal Register — Food and Drug AdministrationOpen original release →