[Federal Register: July 26, 2001 (Volume 66, Number 144)]
[Notices]
[Page 39049-39050]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy01-64]
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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