Docket HopperPart I · Bills · 119th H.R. 1539
H.R. 1539 · 119th CongressHealth

Medical Device Electronic Labeling Act has not moved since its introduction on Feb 24, 2025, with cosponsors split almost evenly between the parties

Sponsored by Obernolte, Jay R-CA · 7 cosponsors: 4 Democrats, 3 Republicans
IntroducedFeb 24, 2025
Reported—
Passed one chamber—
Passed both—
Law—
What it changes · CRS summary

Written by the Congressional Research Service [2]. 170 words.

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.

Context
Committees
House Energy and Commerce Committee
Policy area
Health: 122 of 9,357 bills became law, 113th–118th (1.3%)
Sponsor
1 of 65 bills enacted since 2013
Text versions
1: introduced in house · 380 words
Subjects
Computers and information technologyConsumer affairsDrug safety, medical device, and laboratory regulation
Latest action
Feb 24, 2025: Referred to the House Committee on Energy and Commerce.
Records
Congress.gov · Bill text
Exhibit 1Passage odds band at each stage, rated when the bill reached it [4]
Related bills · 0

The bill status record lists no related bills.

Exhibit 2Articles naming the bill per day, last 90 days, US sources [3]