Draft Guidances for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance documents entitled "Class II Special Controls Guidance Document: Dental Noble Metal Alloys" and "Class II Special Controls Guidance Document: Dental Base Metal Alloys." These draft guidance documents describe means by which noble metal alloy and base metal alloy devices may comply with the requirement of special controls for class II devices.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 final rule to amend the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base metal alloy devices presently classified in class II. FDA is also exempting these devices from premarket notification requirements.