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S4519119th CongressWALLET
Medical Device Electronic Labeling Act
Sponsored By: Senator Banks, Jim [R-IN]
Introduced
Summary
Electronic-only labeling for medical devices: This bill would let manufacturers provide required labeling for devices, including in vitro diagnostic tests, exclusively in electronic form when they meet access and content rules. It also preserves a free paper-on-request option and lets the agency set extra label requirements or narrow exceptions to protect patients.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA can require extra device labels
If enacted, the Secretary of Health and Human Services would be able to issue orders adding requirements to, or creating exceptions from, the electronic-labeling rules for device labels. The Secretary could require extra information for devices intended for use by patients without provider supervision. The Secretary could also limit electronic-only labeling when it would not reasonably assure safety or effectiveness. Any exception would have to say which requirement is waived and explain why. Orders would be published in the Federal Register after a proposed order and public comment.
Device labels online, free paper copies
If enacted, manufacturers could provide required medical device labeling only online, including some in vitro diagnostic devices. The electronic label must meet applicable law and be easy and user-friendly to access. Manufacturers would have to offer an easy way for users to request a paper copy. On request, manufacturers would promptly send the paper labeling at no cost. The device or its immediate container would still need to show all required label information.
Sponsors & CoSponsors
Sponsor
Banks, Jim [R-IN]
IN • R
Cosponsors
Sen. Hickenlooper, John W. [D-CO]
CO • D
Sponsored 5/13/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov