Zdrowie i gospodarka · 17/07/2002
Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Availability; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening for 60 days the comment period on the draft guidance entitled "Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling." Elsewhere in this issue of the Federal Register, the agency is announcing the extension of the comment period on a proposed rule 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 The draft guidance document is intended to serve as a special control for these devices. The agency is taking this action in response to a request for an extension.