[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Notices]
[Pages 64584-64585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4115]


Clarification of Radiation Control Regulations for Manufacturers 
of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Clarification of 
Radiation Control Regulations for Manufacturers of Diagnostic X-Ray 
Equipment.'' This draft guidance provides clarification to industry and 
FDA staff of the Federal regulations that relate to diagnostic x-ray 
systems and their major components. These regulations pertain to the 
recordkeeping, reporting, manufacturing, importing, and installation of 
``electronic products,'' as defined in FDA regulations. This draft 
guidance, when finalized, will supersede FDA's guidance entitled 
``Clarification of Radiation Control Regulations for Diagnostic X-Ray 
Equipment.'' This draft guidance is not final nor is it in effect at 
this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 15, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2018-D-4115 for ``Clarification of Radiation Control Regulations 
for Manufacturers of Diagnostic X-Ray Equipment.'' 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.gpo.gov/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 draft guidance document entitled 
``Clarification of Radiation Control Regulations for Manufacturers of 
Diagnostic X-Ray Equipment'' 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.

FOR FURTHER INFORMATION CONTACT: Scott Gonzalez, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4276, Silver Spring, MD 20993-0002, 301-796-5889.

SUPPLEMENTARY INFORMATION: 

I. Background

    This draft guidance provides clarification to industry and FDA 
staff of the Federal regulations that relate to diagnostic x-ray 
systems and their major components. The Federal Food, Drug, and 
Cosmetic Act (FD&C Act) defines diagnostic x-ray systems as both a 
medical device, under section 201(h) of the FD&C Act (21 U.S.C. 
321(h)), and an electronic product, under section 531 of the FD&C Act 
(21 U.S.C. 360hh). As such, these devices are subject to the provisions 
of the FD&C Act that apply to medical devices (e.g., sections 510

[[Page 64585]]

and 520 of the FD&C Act (21 U.S.C. 360 and 360j)), and their 
implementing regulations as well as the provisions of the FD&C Act 
(sections 531 through 542 of the FD&C Act (21 U.S.C. 360hh through 
360ss)) that apply to electronic products, known as the Electronic 
Product Radiation Control (EPRC) and their implementing regulations. 
These regulations pertain to the recordkeeping, reporting, 
manufacturing, importing, and installation of ``electronic products'' 
as defined under 21 CFR 1000.3(j). This draft guidance, when finalized, 
will supersede FDA's guidance entitled ``Clarification of Radiation 
Control Regulations for Diagnostic X-Ray Equipment'' (HHS Publication 
FDA 89-8221 issued in March 1989).
    This draft guidance addresses only the requirements that apply to 
diagnostic x-ray equipment under the EPRC provisions of the FD&C Act 
and the regulations implementing those provisions. This draft guidance 
does not address requirements that may apply to such equipment as 
medical devices under provisions of the FD&C Act and its implementing 
regulations.

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 current thinking of FDA on 
``Clarification of Radiation Control Regulations for Manufacturers of 
Diagnostic X-Ray Equipment.'' 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 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 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 ``Clarification of 
Radiation Control Regulations for Manufacturers of Diagnostic X-Ray 
Equipment'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1500029 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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:

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                                                            OMB control
            21 CFR part                     Topic               No.
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1002, 1005, 1010, 1020, 1030,       Reporting and              0910-0025
 1040, and 1050.                     Recordkeeping for
                                     Electronic
                                     Products--General
                                     Requirements.
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    Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27236 Filed 12-14-18; 8:45 am]
BILLING CODE 4164-01-P