Rule2025-18080
Radiological Health Regulations; Technical Amendments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 18, 2025
Effective
September 18, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "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" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text.
Full Text
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<title>Federal Register, Volume 90 Issue 179 (Thursday, September 18, 2025)</title>
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[Federal Register Volume 90, Number 179 (Thursday, September 18, 2025)]
[Rules and Regulations]
[Pages 44978-44979]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1010
[Docket No. FDA-2018-N-3303]
Radiological Health Regulations; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA) is making technical
amendments to its radiological health regulations to correct an error.
On January 20, 2023, FDA published a final rule entitled ``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'' that inadvertently
deleted certain existing regulatory text from the Code of Federal
Regulations. This action corrects the error by restoring the
inadvertently deleted regulatory text. This action is editorial in
nature and is intended to ensure accuracy and clarity in FDA's
regulations by restoring inadvertently deleted regulatory text.
DATES: This rule is effective September 18, 2025.
FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of
Policy, Center for Devices and Radiological Health, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5519, Silver Spring, MD 20993-0002, 301-796-5837.
SUPPLEMENTARY INFORMATION:
I. Background
On January 20, 2023, FDA published a final rule entitled
``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'' (88 FR
3638, January 20, 2023). This rule amended Sec. 1010.4(b) (21 CFR
1010.4(b)) to, among other things, permit manufacturers to submit
applications for variances electronically and to remove the requirement
for manufacturers to submit multiple paper copies of variance
applications. FDA did not intend to make any other changes to Sec.
1010.4(b). However, due to an error in FDA's amendatory instructions,
FDA did not instruct the Office of the Federal Register to retain and
renumber the prior content of Sec. 1010.4(b)(1). As a result, the
prior content of Sec. 1010.4(b)(1)(i)-(xi), which listed the required
elements of a variance application, was inadvertently deleted from the
Code of Federal Regulations instead of retained and renumbered under
Sec. 1010.4(b)(2). This action corrects that error by restoring the
inadvertently deleted regulatory text.
II. Description of the Technical Amendments
FDA is amending Sec. 1010.4 by revising paragraph (b)(2) and
adding paragraph
[[Page 44979]]
(b)(3) to restore the text that was inadvertently deleted from the Code
of Federal Regulations. These amendments are editorial in nature and
are intended to ensure accuracy and clarity in FDA's regulations.
III. Notice and Public Comment
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
Under 5 U.S.C. 553(b)(B) of the APA, an agency may, for good cause,
find (and incorporate the finding and a brief statement of reasons in
the rules issued) that notice and public comment procedure on a rule is
impracticable, unnecessary, or contrary to the public interest. FDA has
determined that notice and public comment are unnecessary because these
amendments only make technical changes to restore provisions that were
never intended to be removed. Moreover, during the intervening period
following the inadvertent deletion of the prior content of Sec.
1010.4(b)(1)(i)-(xi), affected parties appear to have been operating
under the assumption that the required elements of a variance
application that were contained in the deleted provisions remained
unchanged. For these reasons, FDA has determined that publishing a
notice of proposed rulemaking and providing opportunity for public
comments is unnecessary.
In addition, FDA finds good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because, as previously stated, FDA did not intend to delete the
longstanding prior content of Sec. 1010.4(b)(1), and affected parties
appear to have been operating under the assumption that the required
elements of a variance application that were contained in the deleted
provisions remained unchanged during the intervening period. As a
result, affected parties do not need time to prepare before the rule
takes effect. Therefore, FDA finds good cause for the amendments to
become effective on the date of publication of this action.
List of Subjects in 21 CFR Part 1010
Administrative practice and procedure, Electronic products,
Exports, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under the authority delegated to the Commissioner of Food and Drugs, 21
CFR part 1010 is amended as follows:
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
0
1. The authority citation for part 1010 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371,
381.
0
2. In Sec. 1010.4, revise paragraph (b)(2) and add paragraph (b)(3) to
read as follows:
Sec. 1010.4 Variances.
* * * * *
(b) * * *
(2) The application for variance shall include the following
information:
(i) A description of the product and its intended use.
(ii) An explanation of how compliance with the applicable standard
would restrict or be inappropriate for this intended use.
(iii) A description of the manner in which it is proposed to
deviate from the requirements of the applicable standard.
(iv) A description of the advantages to be derived from such
deviation.
(v) An explanation of how alternate or suitable means of radiation
protection will be provided.
(vi) The period of time it is desired that the variance be in
effect, and, if appropriate, the number of units the applicant wishes
to manufacture.
(vii) In the case of prototype or experimental equipment, the
proposed location of each unit.
(viii) Such other information required by regulation or by the
Director, Center for Devices and Radiological Health, to evaluate and
act on the application.
(ix) With respect to each nonclinical laboratory study contained in
the application, either a statement that the study was conducted in
compliance with the good laboratory practice regulations set forth in
part 58 of this chapter, or, if the study was not conducted in
compliance with such regulations, a brief statement of the reason for
the noncompliance.
(x) [Reserved]
(xi) If the electronic product is used in a clinical investigation
involving human subjects, is subject to the requirements for
institutional review set forth in part 56 of this chapter, and is
subject to the requirements for informed consent set forth in part 50
of this chapter, the investigation shall be conducted in compliance
with such requirements.
(3) The application for amendment or extension of a variance shall
include the following information:
(i) The variance number and expiration date.
(ii) The amendment or extension requested and basis for the
amendment or extension.
(iii) A description of the effect of the amendment or extension on
protection from radiation produced by the product.
(iv) An explanation of how alternate or suitable means of
protection will be provided.
* * * * *
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18080 Filed 9-17-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 18, 2025.
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