The following links provide additional information related to the FDA's regulation of dental amalgam.
- Summary of Changes to the Classification of Dental Amalgam (Appendix I)
- Final Rule for Dental Amalgam (PDF - 444k) (Appendix II)
- Special Controls Guidance Document (Appendix III)
- White Paper and Addendum (PDF - 559k) (Appendices IV and V)
The following links provide additional information about the FDA’s role in regulating medical devices.
FDA does not regulate the disposal of dental amalgam. The disposal of dental amalgam is regulated by the Environmental Protection Agency (EPA) and state and local authorities. See the following link for EPA guidelines: http://www.epa.gov/waterscience/guide/dental/