FDA expected to rule on amalgam
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Posted May 21, 2009 |
By Jennifer Garvin Washington—On July 27, the U.S. Food and Drug Administration is expected to rule on a classification for encapsulated amalgam.
The FDA has been considering this matter for several years, and the ADA submitted public comment supporting the FDA's proposed rulemaking to classify encapsulated amalgam as a Class II device.
As part of the settlement of a 2006 lawsuit filed against the FDA by multiple plaintiffs, including the anti-amalgam group Moms Against Mercury, the FDA agreed to issue a classification of amalgam decision no later than July 28, 2009, and to post specific statements on the FDA's Web site, including that "amalgam contains mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
The FDA does not currently classify encapsulated amalgam, although it does classify one component of encapsulated amalgam as a Class II device with special controls (relating primarily to proper handling and labeling). In its notice of rulemaking, FDA proposed to classify encapsulated amalgam as a Class II device. What controls might be associated with that classification, if any, are not known at this time.
The ADA supports the FDA's decision to classify amalgam as a Class II device and based on extensive studies and scientific reviews of the material by government and independent organizations worldwide, believes that dental amalgam remains a safe, affordable and durable cavity filling choice for dental patients. For that reason, the Association submitted public comment on the FDA's proposed rulemaking urging the FDA not to require any warnings or restrictions on the use of amalgam.
Anti-amalgam groups asked FDA to classify encapsulated amalgam as a Class III device, the medical device category for products that are considered "high risk." This category has the highest level of regulatory controls, including the requirement to submit a pre-market application. Anti-amalgam groups view this as the equivalent of a ban.
"The ADA is confident the FDA's decision will be based on the weight of scientific evidence," ADA President John S. Findley said, "and the Association is ready to assist members and the public to understand whatever action the FDA takes."
For comprehensive information about dental amalgam, visit www.ada.org/prof/resources/topics/amalgam.asp.
Additionally, members are advised to direct patients seeking more information to www.ada.org/goto/fillings.
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