84 FR 20146 - Policy Clarification for Certain Fluoroscopic Equipment Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy Clarification for Certain Fluoroscopic Equipment Requirements.'' This guidance document intends to clarify FDA's interpretation of certain aspects of the performance standard requirements in FDA's regulations for fluoroscopic equipment.

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20146-20148]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-09406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1344]


Policy Clarification for Certain Fluoroscopic Equipment 
Requirements; Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Policy Clarification 
for Certain Fluoroscopic Equipment Requirements.'' This guidance 
document intends to clarify FDA's interpretation of certain aspects of 
the performance standard requirements in FDA's regulations for 
fluoroscopic equipment.

DATES: The announcement of the guidance is published in the Federal 
Register on May 8, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

[[Page 20147]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1344 for ``Policy Clarification for Certain Fluoroscopic 
Equipment Requirements.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 guidance document entitled 
``Policy Clarification for Certain Fluoroscopic Equipment 
Requirements'' to the Office of Policy, 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.

FOR FURTHER INFORMATION CONTACT: Donald Miller, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4318, Silver Spring, MD 20993-0002, 301-796-3299.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document intends to clarify FDA's interpretation of 
certain aspects of the performance standard requirements in Sec. Sec.  
1020.30 and 1020.32 (21 CFR 1020.30 and 1020.32) for fluoroscopic 
equipment. Specifically, it clarifies FDA's interpretation of 
fluoroscopic irradiation time (Sec.  1020.30(b)), the permissible 
duration of the activation of the x-ray tube in the fluoroscopic mode 
(Sec.  1020.32(c)), and on inclusion of an emergency fluoroscopy mode 
in fluoroscopes.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of September 25, 2014 (79 FR 57559). 
FDA revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Policy Clarification for Certain 
Fluoroscopic Equipment Requirements.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Policy Clarification 
for Certain Fluoroscopic Equipment Requirements'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document 1806 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
the following FDA regulations have been approved by OMB as listed in 
the following table:

[[Page 20148]]



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                                                            OMB control
          21 CFR part                     Topic                 No.
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807, subpart E.................  Premarket Notification.       0910-0120
1020...........................  Reporting and                 0910-0025
                                  Recordkeeping for
                                  Electronic Products--
                                  General Requirements.
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    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09406 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P