H.R. 1539: Medical Device Electronic Labeling Act

119th Congress · introduced 2025-02-24 · Health · Latest: Referred to the House Committee on Energy and Commerce.

federal

Official title

Medical Device Electronic Labeling Act

Plain summary

Medical Device Electronic Labeling Act This bill expands the permitted use of electronic labeling of medical devices to allow directions for use and warning labels for all medical devices to be provided electronically, rather than physically (i.e., affixed to or accompanying the device or its container). (Under current law, direction and warning labels may be provided electronically only for (1) prescription devices intended for use in health care facilities or by health care professionals, and (2) in vitro diagnostic devices intended for use in blood establishments or by health care professionals.) Under the bill, direction and warning labels may be provided solely electronically for all medical devices so long as (1) the electronic label is readily accessible to the device’s intended users, (2) intended users may request a paper label at no additional cost, and (3) the label affixed to the device or its packaging contains all information required under current laws and regulations. The Food and Drug Administration may issue regulations establishing additional requirements or exceptions to these provisions.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

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A “Nay” vote

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What does this mean? (plain words)

Official text

Medical Device Electronic Labeling Act

Source: Congressional Research Service summary (Introduced in House)

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Officials and money

Sponsor: Rep. Obernolte, Jay [R-CA-23] · 7 cosponsors

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Words on this page, explained (1)

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Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-119hr1539.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/119/hr>

Record fed-us-cong119-hr1539 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills