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 The bill amends the Federal Food, Drug, and Cosmetic Act to replace outdated language about physical labeling with a general requirement for "devices (including in vitro diagnostic devices)."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
Floor votes
How they voted
No floor votes recorded yet.
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
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