119-hr1539

[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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