3.0.0
1539
2025-08-12T21:11:53Z
2025-08-12T21:11:53Z
House
H
HR
2025-02-24
119
[Congressional Record Volume 171, Number 36 (Monday, February 24, 2025)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. OBERNOLTE:H.R. 1539.Congress has the power to enact this legislation pursuantto the following:Article 1 section 8[Page H769]
- hsif00
Energy and Commerce Committee
House
Standing
  - Referred To
2025-02-24T17:03:40Z
- 2025-02-24
Referred to the House Committee on Energy and Commerce.
IntroReferral
H11100
2
House floor actions
  - hsif00
Energy and Commerce Committee
- 2025-02-24
Introduced in House
IntroReferral
Intro-H
9
Library of Congress
- 2025-02-24
Introduced in House
IntroReferral
1000
9
Library of Congress
- O000019
Rep. Obernolte, Jay [R-CA-23]
Jay
Obernolte
R
CA
23
N
- M001225
Rep. Mullin, Kevin [D-CA-15]
Kevin
Mullin
D
CA
15
2025-02-24
True
- C001120
Rep. Crenshaw, Dan [R-TX-2]
Dan
Crenshaw
R
TX
2
2025-02-24
True
- C001119
Rep. Craig, Angie [D-MN-2]
Angie
Craig
D
MN
2
2025-02-24
True
- P000608
Rep. Peters, Scott H. [D-CA-50]
Scott
Peters
D
CA
H.
50
2025-04-08
False
- M001215
Rep. Miller-Meeks, Mariannette [R-IA-1]
Mariannette
Miller-Meeks
R
IA
1
2025-04-28
False
- B001257
Rep. Bilirakis, Gus M. [R-FL-12]
Gus
Bilirakis
R
FL
M.
12
2025-05-06
False
Health
- Computers and information technology
2025-07-17T19:28:18Z
- Consumer affairs
2025-07-17T19:28:23Z
- Drug safety, medical device, and laboratory regulation
2025-07-17T19:28:11Z
Health
2025-03-18T14:03:03Z
00
2025-02-24
Introduced in House
2025-08-12T21:11:07Z
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.

Medical Device Electronic Labeling Act
- Display Title
45

Medical Device Electronic Labeling Act
2025-03-17T12:53:28Z
- Short Title(s) as Introduced
101

Medical Device Electronic Labeling Act
2025-03-17T12:53:22Z
Introduced in House
IH
- Official Title as Introduced
6

To amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means, and for other purposes.
2025-03-17T12:48:26Z
Introduced in House
IH
- Introduced in House
2025-02-24T05:00:00Z
  - https://www.govinfo.gov/content/pkg/BILLS-119hr1539ih/xml/BILLS-119hr1539ih.xml
2025-02-24
Referred to the House Committee on Energy and Commerce.
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
Congressional Research Service, Library of Congress
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