Participate in the Immunology Devices Panel Meeting in November 2019
On November 13-14, 2019, the FDA will host a public meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee to discuss metal-containing implants and dental amalgam. Read the FDA's paper on metal-containing implants and paper on dental amalgam for more information on the topics.
You can participate by attending the meeting (either in person or online), presenting at the meeting, or submitting written comments to help inform the FDA's thinking on this topic. Key dates include:
- October 16, 2019: Individuals interested in making formal oral presentations should notify the contact person (FDA.MetalImplants@fda.hhs.gov) and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 16, 2019.
- October 28, 2019: Comments received on or before October 28, 2019, will be provided to the advisory committee panel. Comments received after that date will be taken into consideration by the FDA.
- November 13-14, 2019: Public meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee. The FDA plans to provide a live webcast of the meeting:
- December 16, 2019: The docket will close to comments on December 16, 2019.
Dental amalgam is a dental filling material which is used to fill cavities caused by tooth decay. Its primary component is elemental mercury.
Tooth decay results in a loss of tooth structure. Dental amalgam is one type of dental filling material used to repair tooth structure that has been destroyed by decay and to restore the biting surfaces of a decayed tooth. Other materials, commonly referred to as composites, are also used for dental fillings.
This website contains information about dental amalgam and other types of dental filling materials. It provides general information and is not meant to replace a discussion with your dentist.
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.
The following links provide additional information about sources of mercury exposure and bioaccumulation:
The following link provides additional information about allergy or sensitivity to mercury:
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/