Business · 23/08/2004

FDA Releases Draft Guidance for Dental Noble Metal Alloys and Base Metal Alloys

The Food and Drug Administration (FDA) has released draft guidance documents for dental noble metal alloys and base metal alloys, outlining compliance requirements for Class II devices. The documents are available alongside a final rule amending regulations for gold-based and precious metal alloys, as well as exempting these devices from premarket notification requirements.