```

[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79624-79626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22332]

-----------------------------------------------------------------------

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; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Clarification of 
Radiation Control Regulations for Manufacturers of Diagnostic X-Ray 
Equipment.'' This guidance provides clarification to industry and FDA 
staff of the Federal regulations that relate to diagnostic x-ray 
equipment. These regulations pertain to the recordkeeping, reporting, 
manufacturing, importing, and installation of an ``electronic product'' 
as defined in FDA regulations. This guidance supersedes FDA's 1989 
guidance entitled ``Clarification of Radiation Control Regulations for 
Diagnostic X-Ray Equipment.''

DATES: The announcement of the guidance is published in the Federal 
Register on September 30, 2024.

ADDRESSES: You may submit either electronic or written comments on

[[Page 79625]]

Agency guidances 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 
``Clarification of Radiation Control Regulations for Manufacturers of 
Diagnostic X-Ray Equipment'' to the Office of Policy, 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: Laurel Burk, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3668, Silver Spring, MD 20993-0002, 301-796-5933.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides clarification to industry and FDA staff of 
the Federal regulations that relate to diagnostic x-ray equipment. 
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), diagnostic 
x-ray systems are considered to be both medical devices, under section 
201(h) of the FD&C Act (21 U.S.C. 321(h)), and electronic products, 
under section 531 of the FD&C Act (21 U.S.C. 360hh). As such, they are 
subject to the provisions of the FD&C Act that apply to medical devices 
(e.g., sections 510 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) provisions and their 
implementing regulations. FDA's EPRC regulations pertain to the 
recordkeeping, reporting, manufacturing, importing, and installation of 
an ``electronic product'' as defined under 21 CFR 1000.3(j). This 
guidance supersedes FDA's guidance entitled ``Clarification of 
Radiation Control Regulations for Diagnostic X-Ray Equipment'' (HHS 
Publication FDA 89-8221 issued in March 1989).
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 17, 2018 (83 FR 64584). FDA considered the 
comments received and revised the guidance as appropriate. Revisions 
include the addition of new questions and updates to existing questions 
in the sections related to alternate test methods to demonstrate 
compliance with performance standards, as well as the applicability of 
performance standards to x-ray based image-guidance used with radiation 
therapy devices, certification and associated labeling of certifiable 
components, assembly instructions, accidental radiation occurrence, and 
defects. In addition, FDA revised other questions and responses 
throughout the guidance to provide additional clarification and for 
editorial accuracy. Questions and responses related to certain reports 
that are no longer required were also removed (see ``Radiological 
Health Regulations; Amendments to Records and Reports for Radiation 
Emitting Electronic Products; Amendments to Performance Standards for 
Diagnostic X-ray, Laser, and Ultrasonic Products'' published in the 
Federal Register of January 20, 2023 (88 FR 3638)).
    This guidance is being issued consistent with FDA's good guidance

[[Page 79626]]

practices regulation (21 CFR 10.115). The guidance represents 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.

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 GUI01500029 and 
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following FDA table have been approved by OMB:

------------------------------------------------------------------------
    21 CFR Part or FDA Form             Topic           OMB Control No.
------------------------------------------------------------------------
1002, 1005, 1010, 1020, 1030,   Reporting and                  0910-0025
 1040, and 1050; form FDA 2579   Recordkeeping for
 and form FDA 2877.              Electronic Products--
                                 General Requirements.
800, 801, and 809.............  Labeling.............          0910-0485
812...........................  Investigational                0910-0078
                                 Device Exemption.
``Allegations of Regulatory     Voluntary Allegations          0910-0769
 Misconduct'' form.              of Regulatory
                                 Misconduct.
------------------------------------------------------------------------

    Dated: September 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22332 Filed 9-27-24; 8:45 am]
BILLING CODE 4164-01-P
```