HR1539Referred to Committee
Medical Device Electronic Labeling Act
Introduced
In Committee
3
Passed One Chamber4
Passed Both5
Signed into Law119th
Congress
2025-02-24
Introduced
7
Cosponsors
HR
ⓘType
Sponsor
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 →
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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