0
0
0
Medical Device Nonvisual Accessibility Act of 2021
12/31/2022, 5:04 AM
Summary of Bill HR 4853
Bill 117 HR 4853, also known as the Medical Device Nonvisual Accessibility Act of 2021, aims to improve accessibility for individuals with visual impairments when using medical devices. The bill requires manufacturers of medical devices to ensure that their products are accessible to individuals who are blind or visually impaired.
Specifically, the bill mandates that medical devices must have nonvisual accessibility features, such as audible output or tactile input, to allow individuals with visual impairments to use the devices effectively. This includes features such as speech output, braille labels, and tactile buttons.
The bill also requires manufacturers to provide documentation in accessible formats, such as braille or large print, to ensure that individuals with visual impairments can understand how to use the devices properly. Overall, the Medical Device Nonvisual Accessibility Act of 2021 seeks to promote inclusivity and accessibility in the healthcare industry by ensuring that individuals with visual impairments have equal access to medical devices.
Specifically, the bill mandates that medical devices must have nonvisual accessibility features, such as audible output or tactile input, to allow individuals with visual impairments to use the devices effectively. This includes features such as speech output, braille labels, and tactile buttons.
The bill also requires manufacturers to provide documentation in accessible formats, such as braille or large print, to ensure that individuals with visual impairments can understand how to use the devices properly. Overall, the Medical Device Nonvisual Accessibility Act of 2021 seeks to promote inclusivity and accessibility in the healthcare industry by ensuring that individuals with visual impairments have equal access to medical devices.
Congressional Summary of HR 4853
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.
Read the Full Bill
Current Status of Bill HR 4853
Bill HR 4853 is currently in the status of Bill Introduced since July 29, 2021. Bill HR 4853 was introduced during Congress 117 and was introduced to the House on July 29, 2021. Bill HR 4853's most recent activity was Referred to the Subcommittee on Health. as of July 30, 2021
Bipartisan Support of Bill HR 4853
Total Number of Sponsors
1Democrat Sponsors
1Republican Sponsors
0Unaffiliated Sponsors
0Total Number of Cosponsors
130Democrat Cosponsors
124Republican Cosponsors
6Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 4853
Primary Policy Focus
HealthAlternate Title(s) of Bill HR 4853
To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes.
Medical Device Nonvisual Accessibility Act of 2021
Medical Device Nonvisual Accessibility Act of 2021
Comments
Sponsors and Cosponsors of HR 4853
Latest Bills
Expressing the sense of the House of Representatives that as the United States marks 250 years of independence, establishing a "Veterans Appreciation Month" offers a simple but powerful way for the Nation to recognize the men and women whose service has protected American freedom for generations.
Bill HRES 1204April 22, 2026
Recognizing the 200th anniversary of the heroic Exodus of Missolonghi and commemorating its historical significance to the Greek War of Independence.
Bill HRES 1203April 22, 2026
To amend the Marine Mammal Protection Act of 1972 to allow the transport, purchase, and sale of pelts of, and handicrafts, garments, and art produced from, Southcentral and Southeast Alaska northern sea otters that are taken for subsistence purposes.
Bill HR 8401April 22, 2026
Encouraging military discounts in honor of the 250th anniversary of the United States.
Bill HRES 1205April 22, 2026
Expressing the sense of the House of Representatives that the Department of Justice must comply with the Domestic Emoluments Clause of the Constitution by refusing to administratively settle the billions of dollars in legal claims filed against the United States by President Donald Trump.
Bill HRES 1185April 22, 2026
To prohibit liability against those engaged in the mining, extraction, production, refinement, transportation, distribution, marketing, manufacture, or sale of energy for damages or injunctive or other relief from the use of their products, and for other purposes.
Bill HR 8330April 22, 2026
To amend the Food and Nutrition Act of 2008 to modify the definition of food.
Bill HR 8403April 22, 2026
Supporting the designation of April 19 through April 25, 2026, as "National Crime Victims' Rights Week".
Bill HRES 1190April 22, 2026
Repealing Big Brother Overreach Act
Bill HR 425April 22, 2026
Senior Hunger Prevention Act of 2026
Bill HR 8256April 22, 2026