Medical Device Nonvisual Accessibility Act of 2023
Latest action · Mar 10, 2023 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 1, 2023
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 85
Members who signed on, in the order they did. Signatures ran from Mar 1, 2023 to Jul 30, 2024; 32 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-WA | Adam Smith | Original | Mar 1, 2023 |
| D-MN | Angie Craig | Original | Mar 1, 2023 |
| D-NH | Ann M. Kuster | Original | Mar 1, 2023 |
| D-CA | Barbara Lee | Original | Mar 1, 2023 |
| R-PA | Brian K. Fitzpatrick | Original | Mar 1, 2023 |
| D-MD | C. A. Dutch Ruppersberger | Original | Mar 1, 2023 |
| D-MO | Cori Bush | Original | Mar 1, 2023 |
| D-MI | Daniel T. Kildee | Original | Mar 1, 2023 |
| D-IL | Danny K. Davis | Original | Mar 1, 2023 |
| D-MD | David J. Trone | Original | Mar 1, 2023 |
| D-NV | Dina Titus | Original | Mar 1, 2023 |
| D-HI | Ed Case | Original | Mar 1, 2023 |
| D-VA | Gerald E. Connolly | Original | Mar 1, 2023 |
| D-CT | Jahana Hayes | Original | Mar 1, 2023 |
| D-IL | Jesús G. "Chuy" García | Original | Mar 1, 2023 |
| D-CA | Jimmy Panetta | Original | Mar 1, 2023 |
| D-CT | John B. Larson | Original | Mar 1, 2023 |
| R-FL | John H. Rutherford | Original | Mar 1, 2023 |
| D-MD | John P. Sarbanes | Original | Mar 1, 2023 |
| D-DE | Lisa Blunt Rochester | Original | Mar 1, 2023 |
| D-TX | Marc A. Veasey | Original | Mar 1, 2023 |
| D-WI | Mark Pocan | Original | Mar 1, 2023 |
| D-IL | Mike Quigley | Original | Mar 1, 2023 |
| R-TX | Pete Sessions | Original | Mar 1, 2023 |
| D-MI | Rashida Tlaib | Original | Mar 1, 2023 |
| D-AZ | Raúl M. Grijalva | Original | Mar 1, 2023 |
| D-GA | Sanford D. Bishop, Jr. | Original | Mar 1, 2023 |
| D-IL | Sean Casten | Original | Mar 1, 2023 |
| D-FL | Sheila Cherfilus-McCormick | Original | Mar 1, 2023 |
| D-MA | Stephen F. Lynch | Original | Mar 1, 2023 |
| D-AL | Terri A. Sewell | Original | Mar 1, 2023 |
| D-MA | William R. Keating | Original | Mar 1, 2023 |
| D-VT | Becca Balint | Mar 7, 2023 | |
| D-NJ | Bonnie Watson Coleman | Mar 7, 2023 | |
| D-NH | Chris Pappas | Mar 7, 2023 | |
| D-MI | Debbie Dingell | Mar 7, 2023 | |
| D-FL | Kathy Castor | Mar 7, 2023 | |
| D-CA | Mark DeSaulnier | Mar 7, 2023 | |
| D-NY | Paul Tonko | Mar 7, 2023 | |
| R-NE | Don Bacon | Mar 14, 2023 | |
| D-HI | Jill N. Tokuda | Mar 24, 2023 | |
| D-IL | Raja Krishnamoorthi | Mar 24, 2023 | |
| D-IN | Frank J. Mrvan | Apr 6, 2023 | |
| D-VA | Jennifer L. McClellan | Apr 13, 2023 | |
| D-OH | Joyce Beatty | Apr 17, 2023 | |
| D-WA | Derek Kilmer | Apr 19, 2023 | |
| D-KS | Sharice Davids | Apr 19, 2023 | |
| D-WA | Rick Larsen | May 5, 2023 | |
| D-MD | Kweisi Mfume | Jul 27, 2023 | |
| D-MD | Jamie Raskin | Dec 12, 2023 | |
| D-WA | Suzan K. DelBene | Dec 12, 2023 | |
| D-NJ | Josh Gottheimer | Jan 18, 2024 | |
| D-FL | Maxwell Frost | Jan 18, 2024 | |
| D-FL | Debbie Wasserman Schultz | Feb 1, 2024 | |
| D-MO | Emanuel Cleaver | Feb 1, 2024 | |
| D-TX | Henry Cuellar | Feb 1, 2024 | |
| D-NY | Jerrold Nadler | Feb 1, 2024 | |
| D-CA | Juan Vargas | Feb 1, 2024 | |
| D-TX | Lloyd Doggett | Feb 1, 2024 | |
| D-RI | Seth Magaziner | Feb 1, 2024 | |
| D-PA | Susan Wild | Feb 1, 2024 | |
| D-CA | Brad Sherman | Feb 13, 2024 | |
| D-CO | Brittany Pettersen | Feb 13, 2024 | |
| D-NC | Donald G. Davis | Feb 13, 2024 | |
| D-MD | Glenn Ivey | Feb 13, 2024 | |
| D-CT | James A. Himes | Feb 13, 2024 | |
| D-CO | Joe Neguse | Feb 13, 2024 | |
| D-CA | Kevin Mullin | Feb 13, 2024 | |
| D-CA | Mark Takano | Feb 13, 2024 | |
| D-NM | Melanie A. Stansbury | Feb 13, 2024 | |
| R-NJ | Thomas H. Kean, Jr. | Feb 13, 2024 | |
| D-CO | Yadira Caraveo | Feb 13, 2024 | |
| D-MS | Bennie G. Thompson | Feb 23, 2024 | |
| D-CO | Jason Crow | Feb 23, 2024 | |
| D-IL | Jonathan L. Jackson | Feb 23, 2024 | |
| D-NY | Joseph D. Morelle | Feb 23, 2024 | |
| D-IL | Robin L. Kelly | Feb 23, 2024 | |
| D-FL | Darren Soto | Feb 29, 2024 | |
| R-CA | Mike Garcia | Feb 29, 2024 | |
| D-TN | Steve Cohen | Feb 29, 2024 | |
| D-CA | John Garamendi | Mar 15, 2024 | |
| D-CA | Julia Brownley | Mar 15, 2024 | |
| D-IN | André Carson | Apr 10, 2024 | |
| D-TX | Colin Z. Allred | Apr 10, 2024 | |
| D-NC | Valerie P. Foushee | Jul 30, 2024 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 1, 2023 |
| Health Subcommittee | Referred Mar 10, 2023 |
Actions 3
Everything that happened, newest first.
- Mar 10, 2023Referred to the Subcommittee on Health.
- Mar 1, 2023Introduced in House
- Mar 1, 2023Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 169, no. 39, March 1, 2023, page H1052.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 3621 | Medical Device Nonvisual Accessibility Act of 2024 | Related bill | Jan 18, 2024 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes.
- Short Title(s) as Introduced
- Medical Device Nonvisual Accessibility Act of 2023
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 1, 2023Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
