Document ID: FDA-2014-D-1344-0001
Agency: fda
Document Type: Notice
Title: Policy Clarification for Fluoroscopic Equipment Requirements; Draft
Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2014-09-25T04:00Z

[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57559-57560]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Policy Clarification for 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 This draft guidance describes 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 This draft guidance is not final nor is it 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 24, 2014.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requests for a single hard copy of the draft guidance document entitled 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 
CDRH-Guidance@fda.hhs.gov 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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