Medical Device Electronic Labeling Act
Official title: 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.
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Referred to the House Committee on Energy and Commerce.
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.
- Introduced in House Formatted Text PDF Formatted XML
- MEDTRONIC, INC.
- JOHNSON & JOHNSON SERVICES, INC.
- ADVANCED MEDICAL TECHNOLOGY ASSN
- DEXCOM, INC.
- PHILIPS HOLDING USA, INC.
- THE COOK GROUP INC.
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Centers For Medicare and Medicaid Services (CMS)
- Health & Human Services, Dept of (HHS)
- White House Office
- Food & Drug Administration (FDA)
- Treasury, Dept of
- Commerce, Dept of (DOC)
Cite this page
U.S. Congress. (2026). H.R. 1539: Medical Device Electronic Labeling Act. 119th Congress. Open America. https://openamerica.io/bill/119-HR-1539/
"H.R. 1539: Medical Device Electronic Labeling Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-1539/.
H.R. 1539, 119th Cong. (2026), https://openamerica.io/bill/119-HR-1539/.
[H.R. 1539: Medical Device Electronic Labeling Act](https://openamerica.io/bill/119-HR-1539/)