I
119THCONGRESS
1
STSESSION H. R. 1539
To amend the Federal Food, Drug, and Cosmetic Act to expand the types
of devices for which required labeling may be made available solely
by electronic means, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY24, 2025
Mr. O
BERNOLTE(for himself, Mr. MULLIN, Mr. CRENSHAW, and Ms. CRAIG)
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
expand the types of devices for which required labeling
may be made available solely by electronic means, and
for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Medical Device Elec-4
tronic Labeling Act’’. 5
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SEC. 2. ALLOWING REQUIRED LABELING OF DEVICES TO 1
BE MADE AVAILABLE SOLELY BY ELEC-2
TRONIC MEANS. 3
Section 502(f) of the Federal Food, Drug, and Cos-4
metic Act (21 U.S.C. 352(f)) is amended to read as fol-5
lows: 6
‘‘(f)(1) Unless its labeling bears (A) adequate direc-7
tions for use; and (B) such adequate warnings against use 8
in those pathological conditions or by children where its 9
use may be dangerous to health, or against unsafe dosage 10
or methods or duration of administration or application, 11
in such manner and form, as are necessary for the protec-12
tion of users, except that where any requirement of clause 13
(A) of this subparagraph, as applied to any drug or device, 14
is not necessary for the protection of the public health, 15
the Secretary shall promulgate regulations exempting such 16
drug or device from such requirement. 17
‘‘(2) Subject to subparagraph (3), required labeling 18
for devices (including in vitro diagnostic devices) may be 19
made available solely by electronic means, provided that— 20
‘‘(A) such required labeling is readily accessible 21
to intended users of such devices; 22
‘‘(B) the manufacturer affords intended users 23
of such devices the opportunity to request the re-24
quired labeling in paper form, and upon such re-25
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quest, promptly provides the requested information 1
in paper form without additional cost; and 2
‘‘(C) the label affixed to the device or its imme-3
diate container includes all information in compli-4
ance with this Act and the regulations thereunder or 5
any applicable order of the Secretary under subpara-6
graph (3)(A). 7
‘‘(3)(A) With respect to devices for which labeling is 8
made available solely by electronic means, the Secretary 9
may issue an order establishing requirements in addition 10
to, or exceptions from, the requirements under subpara-11
graph (2) for the label affixed to a device type. 12
‘‘(B) Notwithstanding subchapter II of chapter 5 of 13
title 5, United States Code, such order shall be published 14
in the Federal Register, following publication of a pro-15
posed order in the Federal Register and consideration of 16
comments to a public docket. 17
‘‘(C) Such order may require the label of a device 18
to contain certain information or comply with certain con-19
ditions only if the Secretary determines such requirement 20
is necessary to provide a reasonable assurance of the safe-21
ty and effectiveness of the device.’’. 22
Æ
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