PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · Feb 24, 2025
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.
People & committees
Rep. Obernolte, Jay [R-CA-23] · R–CA
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Mar 25, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-24 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
The bill would let medical-device manufacturers provide required labeling electronically, provided users can readily access it and obtain free paper copies promptly on request. Labels attached to devices or their immediate containers would still need required information. The proposal would also let the Secretary set additional requirements or exceptions for labels on particular device types.
(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.
The proposed replacement text calls for adequate directions for use and warnings needed to protect users. Those warnings address dangerous use with particular medical conditions or by children, as well as unsafe doses, methods, or duration of use.
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
The replacement text would require the Secretary to issue regulations exempting a drug or device from a directions-for-use requirement when that requirement is unnecessary to protect public health. This exception expressly concerns directions, rather than the separate warning requirements.
(A) adequate directions for use;
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.
Electronic labeling would be optional and would include in vitro diagnostic devices. Manufacturers choosing this approach would have to make the labeling readily accessible to intended users, allow paper-copy requests, and promptly provide requested paper copies without an extra charge.
(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;
Using electronic labeling would not eliminate the attached-label requirement. The label on the device or its immediate container would need the information required by the Act, its regulations, or an applicable Secretary's order.
(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).
For devices using electronic labeling, the Secretary could issue orders adding requirements or creating exceptions for attached labels by device type. An order could require particular label information or conditions only if the Secretary determined that requirement was necessary to reasonably assure the device's safety and effectiveness.
(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.
(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.
The Secretary would have to publish a proposed order in the Federal Register, consider comments submitted to a public docket, and then publish the order. The bill specifies this process notwithstanding the cited federal administrative-procedure provisions.
(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.
The supplied actions snapshot, updated March 25, 2026, records introduction in the House and referral to the House Committee on Energy and Commerce on February 24, 2025.
Source snapshot updated 2026-03-25T08:05:37Z. 2025-02-24: Referred to the House Committee on Energy and Commerce. 2025-02-24: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-02-24. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion is limited to that version; member disclosures, committee reports, and other accompanying materials were not supplied.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow preferential treatment was identified in the complete supplied introduced text. The labeling options and safety-based exceptions concern the bill's general regulatory framework. This conclusion does not establish absence in other versions or accompanying materials.
Full text preserved for this analysis. Legislative record snapshot: Mar 25, 2026. How PlainBill uses AI