HR1539Referred to Committee

Medical Device Electronic Labeling Act

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-02-24
Introduced
7
Cosponsors
HR
ⓘ
Type

Sponsor

Jay Obernolte
Jay Obernolte
Republican · CA · Representative
Votes with party: 96.2% (550 recorded votes)

Full profile: /officials/O000019

Source: Congress.gov · FEC

Cosponsors (7)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Referred to the House Committee on Energy and Commerce.

2025-02-24

Source: Congress.gov

Plain-English 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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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