Document ID: FDA-2014-D-0435-0001
Agency: fda
Document Type: Notice
Title: Surveying, Leveling, or Alignment Laser Products; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
Posted Date: 2014-05-05T04:00Z

[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Notices]
[Pages 25597-25598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10189]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0435]

Surveying, Leveling, or Alignment Laser Products; Draft Guidance 
for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Surveying, Leveling, or 
Alignment Laser Products.'' This draft guidance, in question and answer 
format, is intended for manufacturers of laser products and outlines 
the FDA's proposed approach regarding the applicability of FDA's 
performance standard regulations to surveying, leveling, or alignment 
(SLA) laser products. SLA lasers are a subcategory of specific-purpose 
laser products that transmit laser radiation through open space for 
surveying, alignment, or leveling purposes. The draft guidance is not 
final nor is in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 4, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Surveying, Leveling, or Alignment Laser Products'' to the Office of 
the Center Director, Guidance and Policy Development, 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 electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Robert J. Doyle, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301-
796-5863.

I. Background

    This draft guidance is intended to provide a brief summary of the 
FDA's proposed approach on the applicability of performance standards 
for laser products to specific purpose SLA laser products. An SLA laser 
product is defined in 21 CFR 1040.10(b)(39) as ``a laser product 
manufactured, designed, intended or promoted for one or more of the 
following uses: (i) Determining and delineating the form, extent, or 
position of a point, body, or area by taking angular measurement, (ii) 
positioning or adjusting parts in proper relation to one another, (iii) 
defining a plane, level, elevation, or straight line.'' The topics that 
are addressed include the definition of an SLA laser product, examples 
of SLA laser products, design features of SLA laser products, the 
applicability of class limits to SLA laser products, and questions and 
answers relating to the application of FDA's performance standard 
regulations to SLA laser products.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on surveying, 
leveling, or alignment laser products. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all Center for 
Devices and Radiological Health guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

[[Page 25598]]

GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov.
    To receive the ``Surveying, Leveling, or Alignment Laser Products'' 
draft guidance you may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1764 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR 1040.10 and 1040.11 have been 
approved under OMB control number 0910-0025.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments 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: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10189 Filed 5-2-14; 8:45 am]
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