Bill · S. 4519· Senate(119-S-4519)
Medical Device Electronic Labeling Act
- Introduced
- 5/13/2026
- Last activity
- 5/13/2026 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Jim Banks
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
This bill, known as the "Medical Device Electronic Labeling Act," seeks to amend the Federal Food, Drug, and Cosmetic Act. It aims to expand the types of devices for which required labeling can be provided strictly through electronic means. The legislation allows for electronic labeling of devices, including in vitro diagnostic devices, provided certain conditions regarding access and user requests are met. It also gives the Secretary the authority to issue orders that establish additional requirements or exceptions to these electronic labeling rules. Finally, the bill mandates a request for information to help optimize the format and usability of electronic labeling for certain devices.
Yes· 3 of 6
Would people with disabilities be better off under this?+3
The bill mandates that electronic labeling be easy and user-friendly, which supports accessibility for users with various needs.
Does this make health care easier to get in general?+3
The bill aims to optimize the format and usability of electronic labeling to facilitate easier access to device information.
Would households on low incomes be better off under this?+2
The bill ensures that paper labeling must be provided without additional cost upon request, protecting those who cannot access digital information.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Access to Paper Information: Under Section 2(2)(B), manufacturers must allow intended users to request labeling in paper form through easy mechanisms and must provide it promptly without extra cost. This ensures people who cannot or do not want to use electronic versions can still access necessary information.
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User-Friendly Electronic Access: Section 2(2)(A) requires that manufacturers provide intended users with "easy and user-friendly access" to electronic labeling, which aims to ensure the information is reachable for those using the devices.
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Optimization of Labeling: Section 3 requires the Secretary of Health and Human Services to seek information and public comments to "optimize the format, accessibility, and usability" of electronic labeling for specific types of devices.
Potential Negative Impacts for People
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Potential Lack of Immediate Information: While the bill allows for electronic labeling, Section 2(2)(C) requires the label on the device or container to comply with the Act, but the shift to electronic-only access means users must rely on digital access for full required labeling.
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Potential for Safety Concerns if Unsupervised: Section 2(3)(A)(i) notes that the Secretary may require additional information for devices intended for use by patients without provider supervision, implying that relying solely on electronic means might not be sufficient for certain users' safety and effectiveness.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For People With Disabilities+3Good For Low Income Households+2Good For Children+1
- Healthcare
- Improves Healthcare Access+3Increases Research Funding+2
- Governance And Ideology
- Improves Government Transparency+2
- 5/13/2026
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
John HickenlooperDemocrat · Colorado