Rule2025-14203
Regulatory Hearing Before the Food and Drug Administration
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
July 28, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Full Text
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<title>Federal Register, Volume 90 Issue 142 (Monday, July 28, 2025)</title>
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[Federal Register Volume 90, Number 142 (Monday, July 28, 2025)]
[Rules and Regulations]
[Page 35407]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14203]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 16
Regulatory Hearing Before the Food and Drug Administration
CFR Correction
This rule is being published by the Office of the Federal Register
to correct an editorial or technical error that appeared in the most
recent annual revision of the Code of Federal Regulations.
0
In Title 21 of the Code of Federal Regulations, Parts 1 through 99,
revised as of April 1, 2025, reinstate paragraph Sec. 16.1(b)(1) to
read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(1) Statutory provisions:
Section 304(g) of the act relating to the administrative detention
of devices and drugs (see Sec. Sec. 800.55(g) and 1.980(g) of this
chapter).
Section 304(h) of the act relating to the administrative detention
of food for human or animal consumption (see part 1, subpart k of this
chapter).
Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act
relating to the modification or revocation of a variance from the
requirements of section 419 (see part 112, subpart P of this chapter).
Section 515(e)(1) of the act relating to the proposed withdrawal of
approval of a device premarket approval application.
Section 515(e)(3) of the act relating to the temporary suspension
of approval of a premarket approval application.
Section 515(f)(6) of the act relating to a proposed order revoking
a device product development protocol or declaring a protocol not
completed.
Section 515(f)(7) of the act relating to revocation of a notice of
completion of a product development protocol.
Section 516(b) of the act regarding a proposed regulation to ban a
medical device with a special effective date.
Section 518(b) of the act relating to a determination that a device
is subject to a repair, replacement, or refund order or that a
correction plan, or revised correction plan, submitted by a
manufacturer, importer, or distributor is inadequate.
Section 518(e) of the act relating to a cease distribution and
notification order or mandatory recall order concerning a medical
device for human use.
Section 520(f)(2)(D) of the act relating to exemptions or variances
from device current good manufacturing practice requirements (see Sec.
820.1(d)).
Section 520(g)(4) and (g)(5) of the act relating to disapproval and
withdrawal of approval of an application from an investigational device
exemption (see Sec. Sec. 812.19(c), 812.30(c), 813.30(d), and
813.35(c) of this chapter).
Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic
Act relating to the misbranding of tobacco products.
Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act
relating to the establishment of good manufacturing practice
requirements for tobacco products.
Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act
relating to the withdrawal of an order allowing a new tobacco product
to be introduced or delivered for introduction into interstate
commerce.
Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating
to the withdrawal of an order allowing a modified risk tobacco product
to be introduced or delivered for introduction into interstate
commerce.
* * * * *
[FR Doc. 2025-14203 Filed 7-25-25; 8:45 am]
BILLING CODE 0099-10-P
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</html>Indexed from Federal Register on July 28, 2025.
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