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Medical Device Electronic Labeling Act
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.
Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to allow manufacturers of medical devices and in vitro diagnostic devices to provide required labeling information solely through electronic means rather than exclusively on physical labels. Manufacturers would be required to ensure that electronic labeling is readily accessible to intended users and must provide paper copies of labeling upon request at no cost. The physical label affixed to the device or its container must still comply with all legal requirements and FDA regulations. The FDA retains authority to issue orders establishing additional requirements or exceptions for specific device types if necessary to assure device safety and effectiveness. Manufacturers must continue to provide the required safety and usage information on or with the physical device, regardless of electronic labeling availability.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
7 cosponsors
Money behind the sponsor
Top reported contributors to Jay Obernolte’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- NULL $69,760
- GOOGLE $17,500
- ROUTE 66 SHOOTING $13,200
- APPLE VALLEY COMMUNICATIONS $13,200
- CHANDI GROUP USA $13,200
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Jay Obernolte → · Outside spending →
Actions (2)
- Feb 24, 2025 Referred to the House Committee on Energy and Commerce. · house
- Feb 24, 2025 Introduced in House
More bills on these subjects (8)
Other bills that carry the most legislative subjects in common with this one (topical discovery — distinct from the procedural related bills above).
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Text versions (1)
Bills are re-published as they move (Introduced → Reported → Engrossed → Enrolled …). Each stage below is a separate text; pick two to see what changed. Data from Congress.gov.
Full text
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.”. <all>
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