3.0.0 3621 2025-12-05T09:07:48Z 2025-12-05T09:07:48Z Senate S S 2024-01-18 118 https://www.congress.gov/bill/118th-congress/senate-bill/3621 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2024-01-18T18:29:11Z 118 1328 HR 2023-03-10 Referred to the Subcommittee on Health. Related bill CRS 2024-01-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2024-01-18 Introduced in Senate IntroReferral 10000 9 Library of Congress H001076 Sen. Hassan, Margaret Wood [D-NH] Maggie Hassan D NH N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2024-01-18 True Health Administrative law and regulatory procedures 2024-03-21T15:08:32Z Computers and information technology 2024-03-21T15:08:32Z Disability and health-based discrimination 2024-03-21T15:08:32Z Food and Drug Administration (FDA) 2024-03-21T15:08:32Z Health care coverage and access 2024-03-21T15:08:32Z Health technology, devices, supplies 2024-03-21T15:08:32Z Photography and imaging 2024-03-21T15:08:32Z Health 2024-02-09T14:45:39Z

00 2024-01-18 Introduced in Senate 2024-10-24T19:38:35Z <p><strong>Medical Device Nonvisual Accessibility Act of </strong><strong>2024</strong></p><p>This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA).</p><p>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.)</p><p>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.</p>

Display Title 45 2024-07-24T15:19:20Z Short Title(s) as Introduced 101 2024-05-24T13:34:30Z Introduced in Senate IS Official Title as Introduced 6 2024-02-10T09:08:22Z Introduced in Senate IS Introduced in Senate 2024-01-18T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s3621is/xml/BILLS-118s3621is.xml 2024-01-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.