3.0.0
1328
2025-12-05T09:03:16Z
2025-12-05T09:03:16Z
House
H
HR
2023-03-01
118
https://www.congress.gov/bill/118th-congress/house-bill/1328
[Congressional Record Volume 169, Number 39 (Wednesday, March 1, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. SCHAKOWSKY:H.R. 1328.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3The single subject of this legislation is:Accessibility of home-use medical devices for blind andlow-vision Americans.[Page H1052]
- hsif00
Energy and Commerce Committee
House
Standing
  - hsif14
Health Subcommittee
    - Referred to
2023-03-10T18:40:10Z
  - Referred To
2023-03-01T14:09:15Z

- Medical Device Nonvisual Accessibility Act of 2024
118
3621
S
2024-01-18
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  - Related bill
CRS
- 2023-03-10
  - hsif14
Health Subcommittee
1
House committee actions
Referred to the Subcommittee on Health.
Committee
- 2023-03-01
Referred to the House Committee on Energy and Commerce.
IntroReferral
H11100
2
House floor actions
  - hsif00
Energy and Commerce Committee
- 2023-03-01
Introduced in House
IntroReferral
Intro-H
9
Library of Congress
- 2023-03-01
Introduced in House
IntroReferral
1000
9
Library of Congress
- S001145
Rep. Schakowsky, Janice D. [D-IL-9]
JANICE
SCHAKOWSKY
D
IL
D.
9
N
- T000483
Rep. Trone, David J. [D-MD-6]
David
Trone
D
MD
J.
6
2023-03-01
True
- V000131
Rep. Veasey, Marc A. [D-TX-33]
Marc
Veasey
D
TX
A.
33
2023-03-01
True
- B000490
Rep. Bishop, Sanford D., Jr. [D-GA-2]
SANFORD
BISHOP
D
GA
D.
2
2023-03-01
True
- P000613
Rep. Panetta, Jimmy [D-CA-19]
Jimmy
Panetta
D
CA
19
2023-03-01
True
- S001168
Rep. Sarbanes, John P. [D-MD-3]
John
Sarbanes
D
MD
P.
3
2023-03-01
True
- P000607
Rep. Pocan, Mark [D-WI-2]
Mark
Pocan
D
WI
2
2023-03-01
True
- Q000023
Rep. Quigley, Mike [D-IL-5]
Mike
Quigley
D
IL
5
2023-03-01
True
- S000510
Rep. Smith, Adam [D-WA-9]
ADAM
SMITH
D
WA
9
2023-03-01
True
- R000576
Rep. Ruppersberger, C. A. Dutch [D-MD-2]
C. A.
Ruppersberger
D
MD
Dutch
2
2023-03-01
True
- B001224
Rep. Bush, Cori [D-MO-1]
Cori
Bush
D
MO
1
2023-03-01
True
- S000250
Rep. Sessions, Pete [R-TX-17]
PETE
SESSIONS
R
TX
17
2023-03-01
True
- L000557
Rep. Larson, John B. [D-CT-1]
JOHN
LARSON
D
CT
B.
1
2023-03-01
True
- L000551
Rep. Lee, Barbara [D-CA-12]
BARBARA
LEE
D
CA
12
2023-03-01
True
- G000551
Rep. Grijalva, Raúl M. [D-AZ-7]
Raúl
Grijalva
D
AZ
M.
7
2023-03-01
True
- C001117
Rep. Casten, Sean [D-IL-6]
Sean
Casten
D
IL
6
2023-03-01
True
- G000586
Rep. Garcia, Jesus G. "Chuy" [D-IL-4]
Jesus
Garcia
D
IL
G.
4
2023-03-01
True
- R000609
Rep. Rutherford, John H. [R-FL-5]
John
Rutherford
R
FL
H.
5
2023-03-01
True
- L000562
Rep. Lynch, Stephen F. [D-MA-8]
Stephen
Lynch
D
MA
F.
8
2023-03-01
True
- T000468
Rep. Titus, Dina [D-NV-1]
Dina
Titus
D
NV
1
2023-03-01
True
- B001303
Rep. Blunt Rochester, Lisa [D-DE-At Large]
Lisa
Blunt Rochester
D
DE
0
2023-03-01
True
- C001127
Rep. Cherfilus-McCormick, Sheila [D-FL-20]
Sheila
Cherfilus-McCormick
D
FL
20
2023-03-01
True
- C001078
Rep. Connolly, Gerald E. [D-VA-11]
Gerald
Connolly
D
VA
E.
11
2023-03-01
True
- C001055
Rep. Case, Ed [D-HI-1]
Ed
Case
D
HI
1
2023-03-01
True
- K000375
Rep. Keating, William R. [D-MA-9]
William
Keating
D
MA
R.
9
2023-03-01
True
- F000466
Rep. Fitzpatrick, Brian K. [R-PA-1]
Brian
Fitzpatrick
R
PA
K.
1
2023-03-01
True
- D000096
Rep. Davis, Danny K. [D-IL-7]
DANNY
DAVIS
D
IL
K.
7
2023-03-01
True
- T000481
Rep. Tlaib, Rashida [D-MI-12]
Rashida
Tlaib
D
MI
12
2023-03-01
True
- C001119
Rep. Craig, Angie [D-MN-2]
Angie
Craig
D
MN
2
2023-03-01
True
- S001185
Rep. Sewell, Terri A. [D-AL-7]
Terri
Sewell
D
AL
A.
7
2023-03-01
True
- H001081
Rep. Hayes, Jahana [D-CT-5]
Jahana
Hayes
D
CT
5
2023-03-01
True
- K000380
Rep. Kildee, Daniel T. [D-MI-8]
Daniel
Kildee
D
MI
T.
8
2023-03-01
True
- K000382
Rep. Kuster, Ann M. [D-NH-2]
Ann
Kuster
D
NH
M.
2
2023-03-01
True
- D000623
Rep. DeSaulnier, Mark [D-CA-10]
Mark
DeSaulnier
D
CA
10
2023-03-07
False
- P000614
Rep. Pappas, Chris [D-NH-1]
Chris
Pappas
D
NH
1
2023-03-07
False
- D000624
Rep. Dingell, Debbie [D-MI-6]
Debbie
Dingell
D
MI
6
2023-03-07
False
- W000822
Rep. Watson Coleman, Bonnie [D-NJ-12]
Bonnie
Watson Coleman
D
NJ
12
2023-03-07
False
- T000469
Rep. Tonko, Paul [D-NY-20]
Paul
Tonko
D
NY
20
2023-03-07
False
- B001318
Rep. Balint, Becca [D-VT-At Large]
Becca
Balint
D
VT
0
2023-03-07
False
- C001066
Rep. Castor, Kathy [D-FL-14]
Kathy
Castor
D
FL
14
2023-03-07
False
- B001298
Rep. Bacon, Don [R-NE-2]
Don
Bacon
R
NE
2
2023-03-14
False
- T000487
Rep. Tokuda, Jill N. [D-HI-2]
Jill
Tokuda
D
HI
N.
2
2023-03-24
False
- K000391
Rep. Krishnamoorthi, Raja [D-IL-8]
Raja
Krishnamoorthi
D
IL
8
2023-03-24
False
- M001214
Rep. Mrvan, Frank J. [D-IN-1]
Frank
Mrvan
D
IN
J.
1
2023-04-06
False
- M001227
Rep. McClellan, Jennifer L. [D-VA-4]
Jennifer
McClellan
D
VA
L.
4
2023-04-13
False
- B001281
Rep. Beatty, Joyce [D-OH-3]
Joyce
Beatty
D
OH
3
2023-04-17
False
- K000381
Rep. Kilmer, Derek [D-WA-6]
Derek
Kilmer
D
WA
6
2023-04-19
False
- D000629
Rep. Davids, Sharice [D-KS-3]
Sharice
Davids
D
KS
3
2023-04-19
False
- L000560
Rep. Larsen, Rick [D-WA-2]
RICK
LARSEN
D
WA
2
2023-05-05
False
- M000687
Rep. Mfume, Kweisi [D-MD-7]
KWEISI
MFUME
D
MD
7
2023-07-27
False
- D000617
Rep. DelBene, Suzan K. [D-WA-1]
Suzan
DelBene
D
WA
K.
1
2023-12-12
False
- R000606
Rep. Raskin, Jamie [D-MD-8]
Jamie
Raskin
D
MD
8
2023-12-12
False
- F000476
Rep. Frost, Maxwell [D-FL-10]
Maxwell
Frost
D
FL
10
2024-01-18
False
- G000583
Rep. Gottheimer, Josh [D-NJ-5]
Josh
Gottheimer
D
NJ
5
2024-01-18
False
- C001063
Rep. Cuellar, Henry [D-TX-28]
Henry
Cuellar
D
TX
28
2024-02-01
False
- V000130
Rep. Vargas, Juan [D-CA-52]
Juan
Vargas
D
CA
52
2024-02-01
False
- N000002
Rep. Nadler, Jerrold [D-NY-12]
JERROLD
NADLER
D
NY
12
2024-02-01
False
- M001223
Rep. Magaziner, Seth [D-RI-2]
Seth
Magaziner
D
RI
2
2024-02-01
False
- C001061
Rep. Cleaver, Emanuel [D-MO-5]
Emanuel
Cleaver
D
MO
5
2024-02-01
False
- W000826
Rep. Wild, Susan [D-PA-7]
Susan
Wild
D
PA
7
2024-02-01
False
- D000399
Rep. Doggett, Lloyd [D-TX-37]
LLOYD
DOGGETT
D
TX
37
2024-02-01
False
- W000797
Rep. Wasserman Schultz, Debbie [D-FL-25]
Debbie
Wasserman Schultz
D
FL
25
2024-02-01
False
- H001047
Rep. Himes, James A. [D-CT-4]
James
Himes
D
CT
A.
4
2024-02-13
False
- S000344
Rep. Sherman, Brad [D-CA-32]
BRAD
SHERMAN
D
CA
32
2024-02-13
False
- I000058
Rep. Ivey, Glenn [D-MD-4]
Glenn
Ivey
D
MD
4
2024-02-13
False
- N000191
Rep. Neguse, Joe [D-CO-2]
Joe
Neguse
D
CO
2
2024-02-13
False
- P000620
Rep. Pettersen, Brittany [D-CO-7]
Brittany
Pettersen
D
CO
7
2024-02-13
False
- D000230
Rep. Davis, Donald G. [D-NC-1]
Donald
Davis
D
NC
G.
1
2024-02-13
False
- C001134
Rep. Caraveo, Yadira [D-CO-8]
Yadira
Caraveo
D
CO
8
2024-02-13
False
- S001218
Rep. Stansbury, Melanie Ann [D-NM-1]
Melanie
Stansbury
D
NM
Ann
1
2024-02-13
False
- K000398
Rep. Kean, Thomas H. [R-NJ-7]
Thomas
Kean
R
NJ
H.
7
2024-02-13
False
- M001225
Rep. Mullin, Kevin [D-CA-15]
Kevin
Mullin
D
CA
15
2024-02-13
False
- T000472
Rep. Takano, Mark [D-CA-39]
Mark
Takano
D
CA
39
2024-02-13
False
- T000193
Rep. Thompson, Bennie G. [D-MS-2]
BENNIE
THOMPSON
D
MS
2
2024-02-23
False
- C001121
Rep. Crow, Jason [D-CO-6]
Jason
Crow
D
CO
6
2024-02-23
False
- M001206
Rep. Morelle, Joseph D. [D-NY-25]
Joseph
Morelle
D
NY
D.
25
2024-02-23
False
- K000385
Rep. Kelly, Robin L. [D-IL-2]
Robin
Kelly
D
IL
L.
2
2024-02-23
False
- J000309
Rep. Jackson, Jonathan L. [D-IL-1]
Jonathan
Jackson
D
IL
L.
1
2024-02-23
False
- S001200
Rep. Soto, Darren [D-FL-9]
Darren
Soto
D
FL
9
2024-02-29
False
- G000061
Rep. Garcia, Mike [R-CA-27]
Mike
Garcia
R
CA
27
2024-02-29
False
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Rep. Cohen, Steve [D-TN-9]
Steve
Cohen
D
TN
9
2024-02-29
False
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Rep. Garamendi, John [D-CA-8]
John
Garamendi
D
CA
8
2024-03-15
False
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Rep. Brownley, Julia [D-CA-26]
Julia
Brownley
D
CA
26
2024-03-15
False
- C001072
Rep. Carson, André [D-IN-7]
André
Carson
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IN
7
2024-04-10
False
- A000376
Rep. Allred, Colin Z. [D-TX-32]
Colin
Allred
D
TX
Z.
32
2024-04-10
False
- F000477
Rep. Foushee, Valerie P. [D-NC-4]
Valerie
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NC
P.
4
2024-07-30
False
Health
- Administrative law and regulatory procedures
2024-02-12T20:45:25Z
- Computers and information technology
2024-02-12T20:45:25Z
- Disability and health-based discrimination
2024-02-12T20:45:25Z
- Food and Drug Administration (FDA)
2024-02-12T20:45:25Z
- Health care coverage and access
2024-02-12T20:45:25Z
- Health technology, devices, supplies
2024-02-12T20:45:25Z
- Photography and imaging
2024-02-12T20:45:25Z
Health
2023-03-28T17:33:05Z
00
2023-03-01
Introduced in House
2023-09-19T16:50:40Z
Medical Device Nonvisual Accessibility Act of 2023
This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA).
Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.)
A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.

Medical Device Nonvisual Accessibility Act of 2023
- Display Title
45

Medical Device Nonvisual Accessibility Act of 2023
2024-06-11T15:40:09Z
- Short Title(s) as Introduced
101

Medical Device Nonvisual Accessibility Act of 2023
2024-05-24T13:41:59Z
Introduced in House
IH
- Official Title as Introduced
6

To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes.
2024-03-18T20:24:17Z
Introduced in House
IH
- Introduced in House
2023-03-01T05:00:00Z
  - https://www.govinfo.gov/content/pkg/BILLS-118hr1328ih/xml/BILLS-118hr1328ih.xml
2023-03-10
Referred to the Subcommittee on Health.
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.
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