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H.R. 1328 · 118th Congress

Medical Device Nonvisual Accessibility Act of 2023

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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

JSD SchakowskySponsor
85 cosponsors · 79 D, 6 R
SBD Bishop CBD Bush LBD Blunt Rochester ECD Case GCD Connolly SCD Casten ACD Craig SCD Cherfilus-McCormick DDD Davis BFR Fitzpatrick RGD Grijalva CGD García JHD Hayes WKD Keating DKD Kildee AKD Kuster BLD Lee JLD Larson SLD Lynch MPD Pocan JPD Panetta MQD Quigley CRD Ruppersberger JRR Rutherford PSR Sessions ASD Smith JSD Sarbanes TSD Sewell DTD Titus RTD Tlaib DTD Trone MVD Veasey BBD Balint KCD Castor MDD DeSaulnier DDD Dingell CPD Pappas PTD Tonko BWD Watson Coleman DBR Bacon RKD Krishnamoorthi JTD Tokuda FMD Mrvan JMD McClellan JBD Beatty SDD Davids DKD Kilmer RLD Larsen KMD Mfume SDD DelBene JRD Raskin MFD Frost JGD Gottheimer ECD Cleaver HCD Cuellar LDD Doggett SMD Magaziner JND Nadler JVD Vargas DWD Wasserman Schultz SWD Wild YCD Caraveo DDD Davis JHD Himes GID Ivey TKR Kean KMD Mullin JND Neguse BPD Pettersen BSD Sherman MSD Stansbury MTD Takano JCD Crow JJD Jackson RKD Kelly JMD Morelle BTD Thompson SCD Cohen MGR Garcia DSD Soto JBD Brownley JGD Garamendi CAD Allred ACD Carson VFD Foushee

32 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA).

What it does: CRS 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.)

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 nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Medical Device Nonvisual Accessibility Act of 2023

Latest action (Mar 10, 2023): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Mar 1, 2023

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.