Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls

Streszczenie

The Food and Drug Administration (FDA) is proposing to amend the classification regulations of gold-based alloys and precious metal alloys for clinical use and base metal alloy devices. FDA is also proposing to exempt these devices from premarket notification and designate a special control for these devices. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of guidance documents that would serve as special controls for these devices.