Food and Drug Administration

Joint Meeting of the Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health and the Peripheral and Central Nervouse System Drugs Advisory Committee of the Center for Drug Evaluation and Research

September 6-7, 2006

Dental Amalgam Devices

August 11, 2006 Cover Letter to Committee Members and Consultants pdf

Section 1: Draft Agenda pdf

Section 2: Draft FDA White Paper Review of Recent Scientific Studies pdf

Appendix A – Literature Search Criteria for Identification of Relevant Studies pdf
Appendix B – Literature Search Strategy and Terms pdf
Appendix C – Bibliography of Articles Reviewed as Additional Scientific Information pdf
Appendix D – Other Literature Cited pdf
Appendix E - Table Summary of Exposure and Effects from Articles Reviewed pdf
Appendix F - ATSDR-2005 and EPA-2002 update summary documents pdf

1. ATSDR-2005 Mercury Chemical Summaries – Summary memorandum. pdf

2. EPA-2002 Integrated Risk Information System (IRIS) Screening-Level Literature Review: Mercury chloride. pdf

3. EPA-2002 Integrated Risk Information System (IRIS) Screening-Level Literature Review: Mercuric, elemental. pdf

Appendix G1 ATSDR, EPA, and WHO Documents pdf

ATSDR Documents for FDA/NCTR 2006 Review of Literature for Dental Amalgam

1. Mercury Chemical Summaries - Literature Searches - July 2005 Copyrighted

2. Mercury Chemical Summaries - Summary memorandum (of literature review) - July 2005 pdf

3. Mercury Chemical Summaries - Update Criteria Evaluation - July 2005 Copyrighted

4. Criterial for Selecting Toxicological Profiles for Development - March 1993 pdf

5. Email from ATSDR confirming annual review of mercury literature - March 2006 pdf

6. List of ATSDR Chemical Evaluations - 2005 pdf

7. Toxicological Profile for Mercury - 1999 pdf (Document is 676 pages in size. The document has been broken into 6 parts for those who cannot open the complete document.)

Part 1 pdf
Part 2 pdf
Part 3 pdf
Part 4 pdf
Part 5 pdf
Part 6 pdf

EPA Documents for FDA/NCTR 2006 Review of Literature for Denal Amalgam

1. Overview - Screening - Level Review of the Recent Health Effects Literature for IRIS Chemicals - October 2004 pdf

2. Mercury, elemental - IRIS Screening Level Literature Review summary - January 2002 pdf

3. Mercury, elemental - Literature search citations 1998-2002 pdf

4. Mercuric chloride - IRIS Screening Level Literature Review summary - January 2002 pdf

5. Mercuric chloride - Literature search citations 1998-2002 pdf

WHO Documents for FDA/NCTR 2006 Review of Literature for Dental Amalgam

1. Concise International Chemical Assessment Document 50 - 2003 Copyrighted

Appendix G2 – Table of contents - Articles from Recent Peer-reviewed Literature Evaluated in the 2006 FDA Update/Review pdf

Section 3 : Correspondence from the Public

Part 1 pdf
Part 2 pdf
Part 3 pdf

Section 4: Draft Questions for Committee Consideration pdf

Section 5 : References pdf

Overview of Device Classification Process, Heather S. Rosecrans, Center for Devices & Radiological Health - Presentation pdf

Submit Comments:

In the Federal Register of April 3, 2006 (71 FR 16582) the Food and Drug Administration (FDA) announced a Joint Meeting of the Dental Products Panel of the Medical Devices Advisory Committee of the Center for Devices and Radiological Health and the Peripheral and Central CNervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research to be held on September 6 and 7, 2006. The meeting is open to the public. The joint committee will review and discuss peer-reviewed scientific literature on dental amalgam devices.

FDA is opening this public docket (Docket No. 2006N-0352) to receive comments regarding the issues to be reviewed and discussed at that public meeting. FDA is especially interested in comments about the peer-reviewed scientific literature on dental amalgam and its potential mercury toxicity, specifically as it relates to neurotoxic effects.  Dental amalgam, also called "encapsulated amalgam," consists of dental mercury and amalgam alloys. Received comments are public information. Comments are due by November 9, 2006.

To submit comments, copy the URL provided and paste it in your web browser http://www.fda.gov/dockets/ecomments . Then select Docket Search and type in Docket Number 2006N-0352 under Docket ID. Then follow instructions provided.