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This bill would let more medical devices, including in vitro diagnostic devices, meet federal labeling rules by providing the required instructions and warnings electronically instead of on paper. The electronic label would have to be easy for intended users to access, and people would still be able to ask for a paper copy at no extra cost. The bill also keeps a basic label on the device or its container and gives the Food and Drug Administration the power to set extra rules for certain devices when needed for safety and effectiveness.
- Required labeling could be provided only online or by other electronic means for covered devices.
- Manufacturers would have to make the labeling easy for users to find and use.
- If someone asks, the manufacturer would have to send a paper copy promptly and free of charge.
- The FDA could require extra label information or special conditions for certain devices, but only after public notice and comment and only when needed to protect safety and effectiveness.
Official Summaries
Medical Device Electronic Labeling Act
This bill expands the permitted use of electronic labeling of medical devices to allow directions for use and warning labels for all medical devices to be provided electronically, rather than physically (i.e., affixed to or accompanying the device or its container).
(Under current law, direction and warning labels may be provided electronically only for (1) prescription devices intended for use in health care facilities or by health care professionals, and (2) in vitro diagnostic devices intended for use in blood establishments or by health care professionals.)
Under the bill, direction and warning labels may be provided solely electronically for all medical devices so long as (1) the electronic label is readily accessible to the device’s intended users, (2) intended users may request a paper label at no additional cost, and (3) the label affixed to the device or its packaging contains all information required under current laws and regulations.
The Food and Drug Administration may issue regulations establishing additional requirements or exceptions to these provisions.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1539 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
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
February 24, 2025
Mr. Obernolte (for himself, Mr. Mullin, Mr. Crenshaw, and Ms. Craig)
introduced the following bill; which was referred to the Committee on
Energy 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 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 is readily accessible to
intended users of such devices;
``(B) the manufacturer affords intended users of such
devices the opportunity to 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) With respect to devices for which labeling is made
available solely by electronic means, 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
type.
``(B) Notwithstanding subchapter II of chapter 5 of title 5, United
States Code, such order 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.
``(C) Such order may require the label of a device to contain
certain information or comply with certain conditions only if the
Secretary determines such requirement is necessary to provide a
reasonable assurance of the safety and effectiveness of the device.''.
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