E9-18445. Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.” This guidance 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. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify dental amalgam into class II (special controls), reclassify dental mercury from class I (general controls) to class II (special controls), and designate a special controls guidance document to support the class II classification of these two devices, as well as the current class II classification of amalgam alloy.

DATES:

Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Michael Adjodha, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2606, Silver Spring, MD 20993-0002, 301-796-6276.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 20, 2002 (67 FR 7620), FDA issued a proposed rule to issue a separate regulation classifying encapsulated dental amalgam into class II (special controls); amending the class II classification of amalgam alloy by designating special controls; and reclassifying dental mercury from class I (general controls) to class II (special controls). Also, in the Federal Register of February 20, 2002 (67 FR 7703), FDA announced the availability of the draft guidance entitled “Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling,” which would serve as a special control for all three devices. The comment period on the proposed rule closed on May 21, 2002. FDA reopened the comment period in July 2002 (67 FR 46991) and again in April 2008 (73 FR 22877) to provide the public with additional opportunities to comment and to submit data and information that may have become available since publication of the proposed rule. The comment period closed on July 28, 2008.

FDA received more than 1,400 comments on the proposed rule and the draft special controls guidance document. Because of the intertwined nature of the proposed rule and the draft guidance, and because of the significant overlap in comments, FDA considered all comments in preparing both the final rule and the special controls guidance document. The analysis of comments is contained in the preamble to the final rule.

II. Significance of Special Controls Guidance Document

The final rule designates the guidance document entitled “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy” as the special control for mercury, amalgam alloy, and dental amalgam. 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.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1192) to identify the guidance you are requesting.

CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available at http://www.regulations.gov.

IV. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: July 28, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.