02-20500. Medical Devices; Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers.” This draft guidance document was developed as a special control guidance to support the classification of certain dental sonography and jaw tracking devices into class II. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify these device types. This guidance is neither final nor is it in effect at this time.

DATES:

Submit written or electronic comments on the draft guidance by November 12, 2002.

ADDRESSES:

Submit written requests for single copies on a 3.5″ diskette of the draft guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.

Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Mary S. Runner, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283.

SUPPLEMENTARY INFORMATION:

I. Background

FDA developed this draft guidance document as a special control guidance to support the classification of certain dental sonography and jaw tracking devices into class II. FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of dental sonography and jaw tracking devices. This draft guidance document identifies the class, product code, and classification definition for these devices. In addition, it identifies the risks to health generally associated with this generic type of device, describes the device evaluation and labeling measures that FDA believes will mitigate those risks, explains how manufacturers should address those risks in a premarket notification submission, and serves as a special control that, when combined with the general controls, will address the risks associated with this generic device type.

II. Significance of Guidance

This draft guidance document represents the agency's current thinking on certain dental sonography and jaw tracking devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

The agency has adopted good guidance practices (GGPs), and published the final rule, which set forth the agency's regulations for the development, issuance, and use of guidance documents (21 CFR 10.115). This guidance document is issued as a level 1 draft guidance in accordance with the GGP regulations.

III. Electronic Access

In order to receive the draft guidance entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (1393) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the draft guidance may also do so using the Internet. The Center for Devices and Radiological Health (CDRH) maintains an entry on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer. 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 manufacturers' assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. You may access the CDRH home page at http://www.fda.gov/​cdrh. You may search for all CDRH guidance documents at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available at http://www.fda.gov/​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The burden hours associated with 21 CFR part 807, subpart E were approved under OMB control number 0910-0120.

V. Comments

You may submit to the Dockets Management Branch (see ADDRESSES) written comments regarding this draft guidance by November 12, 2002. You should submit two copies of any comments. Individuals may submit one copy. You must identify comments with the docket number found in brackets in the heading of this document. You may see the guidance document and any comments FDA receives in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: August 1, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.