H.R. 1539 · 119th Congress
Medical Device Electronic Labeling Act
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R
ObernolteSponsor7 cosponsors · 4 D, 3 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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).
What it does: CRS summary · Introduced in House · Feb 24, 2025
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Medical Device Electronic Labeling Act
Latest action (Feb 24, 2025): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Feb 24, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.