Laser Products-Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50); Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Laser Products—Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Laser Notice 50).” This guidance document describes the conditions under which laser product manufacturers may introduce into U.S. commerce laser products that comply with the IEC standards 60825-1, as amended, and 60601-2-22. This guidance document also describes additional requirements of the FDA standard and alternate certification statements to be used with such products. This guidance document provides interim relief to manufacturers from conformance with two differing standards and precludes the need for submission of many requests for variances from the FDA standard while FDA harmonizes with many of the IEC requirements for laser products.

DATES:

Submit written or electronic comments concerning this guidance by October 24, 2001.

ADDRESSES:

Submit written requests for single copies on a 3.5′′ diskette of the guidance document entitled “Laser Products—Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Laser Notice 50)” to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), 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 or electronic comments concerning this guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 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 the document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Jerome Dennis, Center for Devices and Radiological Health (HFZ-341), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-4654.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance document describes the conditions under which laser product manufacturers may introduce into United States commerce laser products that comply with the IEC standards 60825-1, as amended, and 60601-2-22. This guidance document also describes additional requirements of the CDRH standard and alternate certification statements to be used with such products. CDRH intends to amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC 60825-1 and 60601-2-22 standards. Although CDRH began its amendment process in anticipation of the amendment of IEC 60825-1, CDRH is not yet ready to publish an amendment. CDRH has acknowledged the advantages of one set of criteria and requirements worldwide. Amendment 2 to IEC 60825-1 was published in January 2001. As a result, manufacturers distributing products in both the United states and countries that require conformance with or that recognize IEC 60825-1 will have to evaluate the conformance of their products with this standard and often change the hazard classification of their products. These manufacturers are requesting relief from CDRH requirements so that they will have only to comply with one laser product radiation safety standard. This guidance supersedes: “Labeling of Laser Products, August 15, 1995 (Laser Notice 45).” See the Electronic Access section for information on this guidance.

FDA is putting this guidance document into effect immediately because the guidance document is presenting a new policy, consistent with public health, that is less burdensome than current policy. This guidance document is appropriate because of the amendment of IEC 60825-1 and the intent of CDRH to harmonize its requirements with many of those of the IEC standards.

II. Significance of Guidance

This guidance document represents the agency's current thinking on appropriate interim relief for manufacturers from differences between the amendments of the IEC and CDRH radiation safety standards for laser products. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An alternative approach may be used if such approach satisfies the applicable statutes and regulations.

The agency has adopted good guidance practices (GGPs) regulation, 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; 65 FR 56468, September 19, 2000). This guidance document is issued as a level 1 guidance consistent with the GGPs.

III. Electronic Access

In order to receive “Laser Products—Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22; (Laser Notice 50)” 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 (1346) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the guidance may also do so using the Internet. 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 the civil money penalty guidance documents package, 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. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Guidance documents are also available on the Dockets Management Branch Web site at http://www.fda.gov/ohrms/dockets/default.htm. Laser Notice 45 may be accessed at www.fda.gov/cdrh/radhlth/index.html under the index heading for “Lasers, Including Light Shows” as a “Notices to Industry.” Scroll to number 92 in the list of notices.

IV. Comments

Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments regarding this guidance by October 24, 2001. Two copies of any comments are to be submitted, except that individuals

may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.