S. 4519

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4519 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
S. 4519

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 SENATE OF THE UNITED STATES

May 13, 2026

Mr. Banks (for himself and Mr. Hickenlooper) introduced the following 
bill; which was read twice and referred to the Committee on Health, 
Education, Labor, and Pensions

_______________________________________________________________________

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Medical Device Electronic Labeling 
Act''.

SEC. 2. ALLOWING REQUIRED LABELING OF DEVICES TO BE MADE AVAILABLE 
SOLELY BY ELECTRONIC MEANS.

Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(f)) is amended to read as follows:
``(f)(1) Unless its labeling bears (A) adequate directions for use; 
and (B) such adequate warnings against use in those pathological 
conditions or by children where its use may be dangerous to health, or 
against unsafe dosage or methods or duration of administration or 
application, in such manner and form, as are necessary for the 
protection of users, except that where any requirement of clause (A) of 
this subparagraph, as applied to any drug or device, is not necessary 
for the protection of the public health, the Secretary shall promulgate 
regulations exempting such drug or device from such requirement.
``(2) Subject to subparagraph (3), required labeling for devices 
(including in vitro diagnostic devices) may be made available solely by 
electronic means, provided that--
``(A) such required labeling complies with all applicable 
requirements of law and the manufacturer provides intended 
users of such devices with easy and user-friendly access to 
such labeling;
``(B) the manufacturer affords intended users of such 
devices the opportunity to request, through easily accessible 
mechanisms for making such request, the required labeling in 
paper form, and upon such request, promptly provides the 
requested information in paper form without additional cost; 
and
``(C) the label affixed to the device or its immediate 
container includes all information in compliance with this Act 
and the regulations thereunder or any applicable order of the 
Secretary under subparagraph (3)(A).
``(3)(A) The Secretary may issue an order establishing requirements 
in addition to, or exceptions from, the requirements under subparagraph 
(2) for the label affixed to a device.
``(B) An order under clause (A) establishing a requirement in 
addition to the requirements under subparagraph (2) may be issued if 
the Secretary determines that--
``(i) such additional requirement is necessary to ensure 
that the label of a device intended for use by patients without 
provider supervision contains certain information or complies 
with certain conditions; or
``(ii) making labeling available solely by electronic means 
would not be sufficient to provide a reasonable assurance of 
the safety and effectiveness of the device.
``(C) An order under clause (A) establishing an exception from the 
requirements under subparagraph (2) shall contain a detailed 
description of which requirement the exception applies to and the 
justification for the exception.
``(D) Notwithstanding subchapter II of chapter 5 of title 5, United 
States Code, an order under this subparagraph shall be published in the 
Federal Register, following publication of a proposed order in the 
Federal Register and consideration of comments to a public docket.''.

SEC. 3. REQUEST FOR INFORMATION AND PUBLIC COMMENT.

Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall post a request for information including a 
public docket in the Federal Register and on a publicly accessible 
website of the Department of Health and Human Services enabling 
stakeholders to submit comments on how to continue to optimize the 
format, accessibility, and usability of electronic labeling of devices 
other than prescription devices intended for use in health care 
facilities or by a health care professional and in vitro diagnostic 
devices intended for use by health care professionals or in blood 
establishments.
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