[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57559-57560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22806]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1344]
Policy Clarification for Fluoroscopic Equipment Requirements;
Draft Guidance for Industry and Food and Drug Administration Staff;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availability of the draft guidance entitled ``Policy Clarification for
Fluoroscopic Equipment Requirements.'' This draft guidance describes
FDA's intent to clarify the application of certain aspects of the
performance standard requirements for fluoroscopic equipment when
manufacturers comply with certain International Electrotechnical
Commission (IEC) standards. This draft guidance is not final nor is it
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 24, 2014.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requests for a single hard copy of the draft guidance document entitled
``Policy Clarification for Fluoroscopic Equipment Requirements'' 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. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Donald Miller, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 20993-0002, 301-796-3299.
SUPPLEMENTARY INFORMATION:
I. Background
The draft guidance document, ``Policy Clarification for
Fluoroscopic Equipment Requirements'' was developed to describe FDA's
intent to clarify the application of certain aspects of the performance
standard requirements in 21 CFR 1020.32 for fluoroscopic equipment when
the manufacturer has complied with certain IEC standards. FDA believes
that a declaration of conformity with the applicable IEC standard and
the applicable measure(s) set forth in this guidance as part of the
510(k) submission for their device will sufficiently address the
concerns intended to be addressed by certain parts of the requirements
of Sec. 1020.32, such that the public health is adequately protected.
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
[[Page 57560]]
represent the Agency's current thinking on the policy clarification for
certain fluoroscopic equipment requirements. 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 downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Policy Clarification for
Fluoroscopic Equipment Requirements'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 1806 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 part 807, subpart E are currently
approved under OMB control number 0910-0120, and the collections of
information in 21 CFR part 1020 have been approved under OMB control
number 0910-0025.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22806 Filed 9-24-14; 8:45 am]
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