Medical Device Nonvisual Accessibility Act of 2025
- Bill Number
- H.R. 5605
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-09-26: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-06-10T08:07:56Z
AI-Generated Summary
Purpose The legislation aims to require certain medical devices with digital interfaces to be accessible for blind or low-vision users, allowing them to operate the devices privately, independently, and safely in home settings.
Key Provisions
- Establishes a nonvisual accessibility standard for user interfaces on covered devices, requiring them to provide blind or low-vision individuals with access to information and interactions that match the effectiveness, privacy, independence, and ease of use available to those without vision impairments.
- Allows the Secretary of Health and Human Services to grant waivers if compliance would fundamentally alter the device's nature or impose undue hardship on the manufacturer, based on clear evidence.
- Requires the Secretary to develop and provide training for manufacturers on the standard and compliance.
- Mandates consultation with the Architectural and Transportation Barriers Compliance Board and blind or low-vision individuals when creating the standard and training.
- Directs the Secretary to issue proposed regulations within one year of enactment and a final rule within two years, with the rule taking effect one year after publication.
- Amends the Federal Food, Drug, and Cosmetic Act to classify non-compliant covered devices as adulterated, starting on the rule's effective date.
Significant Changes to Existing Law
- Adds a new Section 515D to the Federal Food, Drug, and Cosmetic Act, creating specific nonvisual accessibility requirements for certain devices.
- Modifies Section 501 of the Act by adding a new paragraph (k) that links non-compliance with the new standard to adulteration rules, expanding regulatory oversight of device marketing and approval.
Potential Impacts
- On government agencies: Increases responsibilities for the Food and Drug Administration (FDA) in developing regulations, conducting training, and reviewing waiver requests.
- On citizens: Improves independent use of home medical devices for blind or low-vision individuals, potentially reducing errors and enhancing safety.
- On manufacturers: Requires design changes for new class II and III devices cleared or approved after the effective date, with possible cost considerations for compliance.
- International relations are not directly addressed in the bill.
Main Stakeholders Affected
- Manufacturers of class II and III medical devices with user interfaces intended for home use.
- The Food and Drug Administration and the Architectural and Transportation Barriers Compliance Board.
- Individuals who are blind or have low vision who rely on home medical devices.
- Healthcare providers and patients using devices such as blood pressure monitors or sleep apnea machines.
Notable Legal, Constitutional, or Political Implications
- Introduces new accessibility mandates tied to device approval processes, which could lead to regulatory challenges regarding waiver determinations or definitions of "undue hardship."
- Aligns with broader disability access principles by treating nonvisual access as a core design requirement, without altering existing constitutional frameworks for medical device regulation.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Schakowsky, Janice D. [D-IL-9]
Cosponsors (23)
Rep. Bacon, Don [R-NE-2], Rep. Bishop, Sanford D. [D-GA-2], Rep. Casten, Sean [D-IL-6], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. García, Jesús G. "Chuy" [D-IL-4], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Panetta, Jimmy [D-CA-19], Rep. Pocan, Mark [D-WI-2], Rep. Quigley, Mike [D-IL-5], Rep. Rutherford, John H. [R-FL-5], Rep. Sessions, Pete [R-TX-17], Rep. Smith, Adam [D-WA-9], Rep. Hayes, Jahana [D-CT-5], Rep. Craig, Angie [D-MN-2], Rep. Lynch, Stephen F. [D-MA-8], Rep. Ross, Deborah K. [D-NC-2], Rep. Walkinshaw, James R. [D-VA-11], Rep. Doggett, Lloyd [D-TX-37], Rep. McClellan, Jennifer L. [D-VA-4], Rep. Frost, Maxwell [D-FL-10], Rep. Raskin, Jamie [D-MD-8], Rep. McBath, Lucy [D-GA-6], Rep. Latimer, George [D-NY-16]
Recent Actions
- 2025-09-26: Referred to the House Committee on Energy and Commerce.
- 2025-09-26: Introduced in House
- 2025-09-26: Introduced in House
Bill Versions
- Medical Device Nonvisual Accessibility Act of 2025 — issued 2025-09-26 — PDF (7 pages)