Zdrowie i gospodarka · 20/02/2002
Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling." This draft guidance is neither final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, the agency is proposing to classify encapsulated amalgam into class II, to amend the classification regulation for amalgam alloy to provide for special controls, and to reclassify dental mercury into class II. The draft guidance document is intended to serve as a special control for these devices.