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118th Congress Health

H.R. 1328: Medical Device Nonvisual Accessibility Act of 2023

Introduced

  1. Introduced (completed)Mar 1, 2023
  2. Passed House (not reached)
  3. Passed Senate (not reached)
  4. To the President (not reached)
  5. Became law (not reached)

Summary

Introduced in House, Mar 1, 2023

Medical Device Nonvisual Accessibility Act of 2023

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.)

Read the full summary

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.

Written by the Congressional Research Service, Library of Congress.

Roll calls

0 votes on this bill

No roll call votes have been held on this bill.

Amendments

0 offered

No amendments were offered to this bill.

Cosponsors

85

Bipartisan support.

Who scored on this bill

18 points earned
  1. 1Janice Schakowsky D-IL SponsorDrew cross-party cosponsors, reached a cosponsor milestone, introduced4 events+18
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Introductions and cosponsorships count toward weekly caps and show no points.

History

  1. Mar 1, 2023Introduced in the House by Janice Schakowsky.
Show the full action history (3 actions)
  1. Mar 10, 2023Referred to the Subcommittee on Health.
  2. Mar 1, 2023Introduced in House
  3. Mar 1, 2023Referred to the House Committee on Energy and Commerce.