[Federal Register Volume 66, Number 144 (Thursday, July 26, 2001)]
[Notices]
[Pages 39049-39050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0274]


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.

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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

[[Page 39050]]

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.

    Dated: July 13, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-18598 Filed 7-25-01; 8:45 am]
BILLING CODE 4160-01-S