HR1539119th CongressWALLET

Medical Device Electronic Labeling Act

Sponsored By: Representative Obernolte

Introduced

Summary

Allows medical device labeling to be provided electronically instead of only on paper. The bill would let manufacturers post required device labeling online if the information is easy for intended users to access and paper copies are provided on request at no cost.

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  • Manufacturers: Would be permitted to supply required labeling electronically for most devices, including in vitro diagnostic devices, but must give users a free paper copy if requested.
  • Patients and clinicians: Intended users must be able to readily access electronic labeling and can get a prompt paper version at no extra charge.
  • Federal regulators: The Secretary of Health and Human Services could issue orders adding requirements or exemptions for devices with electronic labeling. Any such order must be published in the Federal Register after a proposed order and public comment, and may require label content only to reasonably assure device safety and effectiveness.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Electronic medical device labels, free paper

If enacted, manufacturers could provide required labels for medical devices, including in vitro diagnostic devices, only online. Electronic labels would need to be easy for intended users to find. You could request a paper copy and get it quickly at no cost. The device or its container would still need a physical label with required information. The Secretary could add or waive label rules for certain device types after a proposed order and public comments, when needed for safety and effectiveness.

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Sponsors & CoSponsors

Sponsor

Obernolte

CA • R

Cosponsors

  • Rep. Mullin, Kevin [D-CA-15]

    CA • D

    Sponsored 2/24/2025

  • Crenshaw

    TX • R

    Sponsored 2/24/2025

  • Craig

    MN • D

    Sponsored 2/24/2025

  • Peters

    CA • D

    Sponsored 4/8/2025

  • Miller-Meeks

    IA • R

    Sponsored 4/28/2025

  • Bilirakis

    FL • R

    Sponsored 5/6/2025

  • Rep. Gottheimer, Josh [D-NJ-5]

    NJ • D

    Sponsored 3/24/2026

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov

Live Policy Activity

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Surfaced from PRIA's policy knowledge graph — ranked by signal strength, connected by evidence.

Live · 5h ago15,853Bills1,439Wiki4 signals surfaced
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Moving· 6 days in stage

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Rep. Joyce, David P. [R-OH-14] (R-OH)
IntroducedApr 24
Cmte Reported
Passed Origin Chbr
Passed Second Chbr
Resolving Diffs
Enrolled
Became Law
Current StageIntroduced· 6d

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How These Connect

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