In May, the FDA reopened public comments on its Class II “with special controls” classification of precapsulated mercury amalgam. This means that “general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls.” These include things like “special labeling requirements, mandatory performance standards and postmarket surveillance.”
Groups working to eliminate the use of mercury in dentistry would at least like to see precapsulated mercury amalgam placed in the Class III category. Such “devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.”
The scientific record makes it clear: mercury amalgam fillings present real risks.
The deadline for submitting comments on this important topic is Monday, July 28. To speak up and share your knowledge and views with the FDA, just visit regulations.gov, search for FDA-2008-N-0163 and follow the instructions.