What does Preamble of Medical Device Electronic Labeling Act do?

This bill proposes to amend the Federal Food, Drug, and Cosmetic Act. The proposed amendment would expand the types of devices for which required labeling can be provided solely through electronic means. The bill's stated purpose is to expand the availability of electronic labeling for certain devices and for other purposes.

What does SHORT TITLE. of Medical Device Electronic Labeling Act do?

This bill is formally titled the Medical Device Electronic Labeling Act.

What does ALLOWING REQUIRED LABELING OF DEVICES TO BE MADE AVAILABLE of Medical Device Electronic Labeling Act do?

This section amends the Federal Food, Drug, and Cosmetic Act to allow required labeling of devices to be made available solely by electronic means. The electronic labeling must comply with all applicable requirements of law and provide easy access to users. Manufacturers must provide users with the option to request paper labeling and provide it without additional cost. The Secretary may issue orders establishing additional requirements or exceptions for device labeling. Orders must be published in the Federal Register and consider public comments.

What does REQUEST FOR INFORMATION AND PUBLIC COMMENT. of Medical Device Electronic Labeling Act do?

The Secretary of Health and Human Services must post a request for information within 2 years of enactment. A public docket will be created for stakeholders to submit comments on electronic labeling of certain devices. The focus is on optimizing format, accessibility, and usability of electronic labeling for non-prescription devices and in vitro diagnostic devices.

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Medical Device Electronic Labeling Act

Last updated: 5/13/2026 · Introduced: 5/13/2026

Author: Jim Banks (R-IN)

TL;DR (AI)

This bill amends the Federal Food, Drug, and Cosmetic Act to permit manufacturers to provide required device labeling solely through electronic means, provided it remains accessible and compliant with existing regulations.
Manufacturers must offer users the option to receive paper labeling without additional cost, even when electronic labeling is provided.
The Secretary of Health and Human Services will solicit public comments and may issue orders to establish further requirements or exceptions for electronic device labeling.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 2 more.

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