Medical Device Nonvisual Accessibility Act of 2021
Latest action · Jul 30, 2021 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.
- IntroducedJul 29, 2021
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Medical Device Nonvisual Accessibility Act of 2021
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.
Cosponsors 65
Members who signed on, in the order they did. Signatures ran from Aug 10, 2021 to Nov 7, 2022.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CA | Barbara Lee | Aug 10, 2021 | |
| D-NC | Deborah K. Ross | Aug 23, 2021 | |
| D-VA | Gerald E. Connolly | Aug 23, 2021 | |
| D-WI | Mark Pocan | Aug 23, 2021 | |
| D-NY | Joseph D. Morelle | Sep 17, 2021 | |
| D-CA | Tony Cárdenas | Sep 17, 2021 | |
| D-WA | Adam Smith | Oct 19, 2021 | |
| D-NJ | Mikie Sherrill | Oct 25, 2021 | |
| D-AZ | Raúl M. Grijalva | Nov 18, 2021 | |
| D-IL | Sean Casten | Nov 18, 2021 | |
| D-NJ | Donald M. Payne, Jr. | Feb 8, 2022 | |
| D-NH | Chris Pappas | Feb 9, 2022 | |
| D-IA | Cynthia Axne | Feb 9, 2022 | |
| D-FL | Darren Soto | Feb 9, 2022 | |
| R-WA | Jaime Herrera Beutler | Feb 9, 2022 | |
| D-CA | Jimmy Panetta | Feb 9, 2022 | |
| D-CA | Linda T. Sánchez | Feb 9, 2022 | |
| D-WI | Ron Kind | Feb 9, 2022 | |
| D-IN | Frank J. Mrvan | Feb 18, 2022 | |
| D-MD | Jamie Raskin | Feb 18, 2022 | |
| D-CA | Jim Costa | Feb 18, 2022 | |
| D-CO | Joe Neguse | Feb 18, 2022 | |
| D-KY | John A. Yarmuth | Feb 18, 2022 | |
| D-MD | Kweisi Mfume | Feb 18, 2022 | |
| D-CA | Pete Aguilar | Feb 18, 2022 | |
| D-IL | Raja Krishnamoorthi | Feb 18, 2022 | |
| D-GA | Sanford D. Bishop, Jr. | Feb 18, 2022 | |
| D-AZ | Ann Kirkpatrick | Feb 28, 2022 | |
| D-IL | Danny K. Davis | Feb 28, 2022 | |
| D-GA | David Scott | Feb 28, 2022 | |
| D-CT | Jahana Hayes | Feb 28, 2022 | |
| D-CA | Juan Vargas | Feb 28, 2022 | |
| D-CA | Judy Chu | Feb 28, 2022 | |
| D-CA | John Garamendi | Mar 7, 2022 | |
| D-CA | Josh Harder | Mar 7, 2022 | |
| D-IL | Marie Newman | Mar 7, 2022 | |
| D-MI | Rashida Tlaib | Mar 7, 2022 | |
| D-CA | Ted Lieu | Mar 7, 2022 | |
| D-NC | G. K. Butterfield | Mar 9, 2022 | |
| D-RI | James R. Langevin | Mar 9, 2022 | |
| D-FL | Debbie Wasserman Schultz | Mar 18, 2022 | |
| R-NE | Don Bacon | Mar 18, 2022 | |
| D-OR | Peter A. DeFazio | Mar 18, 2022 | |
| D-MA | Stephen F. Lynch | Mar 18, 2022 | |
| D-CA | Karen Bass | Apr 7, 2022 | |
| D-GA | Lucy McBath | Apr 7, 2022 | |
| D-TX | Marc A. Veasey | Apr 7, 2022 | |
| D-IL | Jesús G. "Chuy" García | Apr 28, 2022 | |
| R-FL | John H. Rutherford | Apr 28, 2022 | |
| D-FL | Al Lawson, Jr. | May 11, 2022 | |
| D-CA | Grace F. Napolitano | May 11, 2022 | |
| D-MA | James P. McGovern | May 11, 2022 | |
| D-DE | Lisa Blunt Rochester | May 11, 2022 | |
| D-MD | John P. Sarbanes | May 19, 2022 | |
| D-MD | Anthony G. Brown | May 24, 2022 | |
| D-MN | Angie Craig | Jun 8, 2022 | |
| D-MD | C. A. Dutch Ruppersberger | Jun 8, 2022 | |
| D-IL | Mike Quigley | Jun 21, 2022 | |
| D-MO | Cori Bush | Jul 12, 2022 | |
| D-MD | David J. Trone | Jul 12, 2022 | |
| D-LA | Troy A. Carter | Jul 12, 2022 | |
| D-FL | Sheila Cherfilus-McCormick | Aug 5, 2022 | |
| D-RI | David N. Cicilline | Sep 13, 2022 | |
| D-CT | John B. Larson | Nov 7, 2022 | |
| D-CA | Mark DeSaulnier | Nov 7, 2022 |
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 Jul 29, 2021 |
| Health Subcommittee | Referred Jul 30, 2021 |
Actions 3
Everything that happened, newest first.
- Jul 30, 2021Referred to the Subcommittee on Health.
- Jul 29, 2021Introduced in House
- Jul 29, 2021Referred 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. 167, no. 133, July 29, 2021, page H4295.
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 2021
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Jul 29, 2021Introduced 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.
