[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of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and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the availability of the draft guidance entitled ``Clarification of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 This draft guidance provides clarification to industry and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 This draft
guidance, when finalized, will supersede FDA's guidance entitled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 This draft guidance is not final nor is it in effect at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DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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