HR 3723 United States House · 118th Congress

Medical Device Electronic Labeling Act

HR 3723, the Medical Device Electronic Labeling Act, allows medical device manufacturers to provide required labeling exclusively through electronic means instead of physical labels. This change directly affects manufacturers of prescription devices and in vitro diagnostic devices, removing the prior requirement for physical labeling at the point of use in healthcare facilities or blood establishments. The bill amends the Federal Food, Drug, and Cosmetic Act to replace outdated language about physical labeling with a general requirement for "devices (including in vitro diagnostic devices)." This simplifies compliance by enabling digital solutions like QR codes or online portals for labeling information. The policy change is a direct regulatory update with no new funding or enforcement mechanisms.
Bill status in committee 1 of 4 stages cleared
Introduction
May 2023
Committee Review
Floor Vote
President
Introduced May 25, 2023 Last action May 26, 2023
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Full legislative history

Actions timeline

Total actions
3
Key actions
0
Committee
2
May 26, 2023
Committee
Referred to the Subcommittee on Health.
lower
May 25, 2023
Committee
Referred to the House Committee on Energy and Commerce.
lower
May 25, 2023
Introduced
Introduced in House
lower
1 primary · 5 co-sponsors

Sponsors