What does Preamble of Medical Device Electronic Labeling Act do?

This bill proposes to amend the Federal Food, Drug, and Cosmetic Act. The amendment aims to expand the types of devices for which required labeling can be provided solely through electronic means. The bill is introduced by Mr. Obernolte, along with Mr. Mullin, Mr. Crenshaw, and Ms. Craig.

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 Section 502(f) of the Federal Food, Drug, and Cosmetic Act. It allows required labeling for devices, including in vitro diagnostic devices, to be made available solely by electronic means. To qualify, the electronic labeling must be readily accessible to intended users and the manufacturer must provide paper copies upon request without additional cost. The label affixed to the device or its container must include required information. The Secretary can issue orders establishing additional requirements or exceptions for labels on device types. Such orders must be published in the Federal Register after a proposed order and consideration of public comments. The Secretary can only require certain information on device labels if it's necessary to ensure safety and effectiveness.

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Medical Device Electronic Labeling Act

Last updated: 2/24/2025 · Introduced: 2/24/2025

Author: Jay Obernolte (R-CA)

TL;DR (AI)

This bill amends the Federal Food, Drug, and Cosmetic Act to permit medical device labeling to be provided solely through electronic means, provided it is readily accessible and paper copies are available upon request.
The bill requires that a physical label on the device or its container still include essential information.
The Secretary of Health and Human Services can establish additional requirements or exceptions for electronic labeling through a public comment process.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 1 more.

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