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Medical Device Nonvisual Accessibility Act of 2023

H.R. 1328 Rep. JANICE SCHAKOWSKY (D-IL-9) In committee
Bill text PDF
  1. Introduced Mar 1
  2. Committee Mar 1
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Mar 1, 2023Next: House vote
1328d ago Mar 10, 2023: Referred to the Subcommittee on Health.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
1company, 1 filing
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Summary

Medical Device Nonvisual Accessibility Act of 2023

Full summary3 paragraphs

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.

Library of Congress summary, Mar 1, 2023

Summary versions
  • Introduced in HouseMar 1, 2023

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.