The U.S. FDA has issued its new guidance document on amalgam, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy."
The document describes a means by which manufacturers of dental amalgam, mercury, and amalgam alloy may comply with special controls that apply to these class II devices, the agency said in a statement.
The FDA also stated the following:
FDA believes that adherence to the recommendations described in this guidance document, in addition to the general controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), will provide reasonable assurance of the safety and effectiveness of dental amalgam, mercury, and amalgam alloy. Following the effective date of the final rule, any firm submitting a 510(k) premarket notification for dental amalgam, mercury, or amalgam alloy, as well as any firm currently marketing the devices, must address the issues covered in the special controls guidance. The firm must show that its device addresses the issues of safety and effectiveness identified in the special controls guidance, either by following the recommendations in the guidance or by some other means that provides equivalent assurances of safety and effectiveness.
The FDA invites written or electronic comments on this guidance at any time.
To request a copy of the guidance document, send an e-mail request to [email protected] to receive an electronic copy, or send a fax request to 301-847-8149 to receive a hard copy. Use the document number (1192) to identify the guidance you are requesting.
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