[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Notices]
[Pages 25597-25598]
From the Federal Register Online via the Government Publishing 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Surveying, Leveling, or Alignment Laser Products; Draft Guidance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availability of the draft guidance entitled ``Surveying, Leveling, or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 This draft guidance, in question and answer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 The draft guidance is not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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 4, 2014.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requests for a single hard copy of the draft guidance document entitled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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 [email protected] 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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