Zdrowie i gospodarka · 1.12.2003
Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance documents entitled "Class II Special Controls Guidance Document: Dental Precious Metal Alloys" and "Class II Special Controls Guidance Document: Dental Base Metal Alloys." These guidance documents describe means by which gold-based alloys and precious metal alloys for clinical use and base metal alloy devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to amend the classification regulations of gold-based alloys and precious metal alloys for clinical use and base metal alloy devices presently classified in class II. In the proposed rule, FDA is also proposing to exempt these devices from premarket notification.