Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
FDA received more than 1,400 comments on the proposed rule and the draft special controls guidance document. Because of the intertwined nature of the proposed rule and the draft guidance, and because of the significant overlap in comments, FDA considered all comments in preparing both the final rule and the special controls guidance document. The analysis of comments is contained in the preamble to the final rule.
The final rule designates the guidance document entitled “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy” as the special control for mercury, amalgam alloy, and dental amalgam. FDA believes that adherence to the recommendations described in this guidance document, in addition to the general controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy” you may either send an e-mail request to
CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts,
Interested persons may submit to the Division of Dockets Management (see