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Medical Device Electronic Labeling Act

USA119th CongressHR-1539| House 
| Updated: 2/24/2025
Jay Obernolte

Jay Obernolte

Republican Representative

California

Cosponsors (6)
Mariannette Miller-Meeks (Republican)Scott H. Peters (Democratic)Angie Craig (Democratic)Gus M. Bilirakis (Republican)Dan Crenshaw (Republican)Kevin Mullin (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Medical Device Electronic Labeling Act" proposes to amend the Federal Food, Drug, and Cosmetic Act, specifically Section 502(f), to expand the types of medical devices for which required labeling may be made available solely by electronic means. This change applies to all devices, including in vitro diagnostic devices, provided that the electronic labeling is readily accessible to their intended users. A key provision mandates that manufacturers must afford intended users the opportunity to request the required labeling in paper form, and upon such a request, must promptly provide the information without any additional cost. Additionally, the physical label affixed to the device or its immediate container must still comply with all existing regulations and any applicable orders issued by the Secretary. The Secretary of Health and Human Services is granted authority to issue orders establishing further requirements or exceptions for electronic labeling, but only if deemed necessary to provide a reasonable assurance of the device's safety and effectiveness.
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Timeline

Bill from Previous Congress

HR 118-3723
Medical Device Electronic Labeling Act
Feb 24, 2025
Introduced in House
Feb 24, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 118-3723
    Medical Device Electronic Labeling Act


  • February 24, 2025
    Introduced in House


  • February 24, 2025
    Referred to the House Committee on Energy and Commerce.

Health

Computers and information technologyConsumer affairsDrug safety, medical device, and laboratory regulation

Medical Device Electronic Labeling Act

USA119th CongressHR-1539| House 
| Updated: 2/24/2025
The "Medical Device Electronic Labeling Act" proposes to amend the Federal Food, Drug, and Cosmetic Act, specifically Section 502(f), to expand the types of medical devices for which required labeling may be made available solely by electronic means. This change applies to all devices, including in vitro diagnostic devices, provided that the electronic labeling is readily accessible to their intended users. A key provision mandates that manufacturers must afford intended users the opportunity to request the required labeling in paper form, and upon such a request, must promptly provide the information without any additional cost. Additionally, the physical label affixed to the device or its immediate container must still comply with all existing regulations and any applicable orders issued by the Secretary. The Secretary of Health and Human Services is granted authority to issue orders establishing further requirements or exceptions for electronic labeling, but only if deemed necessary to provide a reasonable assurance of the device's safety and effectiveness.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 118-3723
Medical Device Electronic Labeling Act
Feb 24, 2025
Introduced in House
Feb 24, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 118-3723
    Medical Device Electronic Labeling Act


  • February 24, 2025
    Introduced in House


  • February 24, 2025
    Referred to the House Committee on Energy and Commerce.
Jay Obernolte

Jay Obernolte

Republican Representative

California

Cosponsors (6)
Mariannette Miller-Meeks (Republican)Scott H. Peters (Democratic)Angie Craig (Democratic)Gus M. Bilirakis (Republican)Dan Crenshaw (Republican)Kevin Mullin (Democratic)

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Computers and information technologyConsumer affairsDrug safety, medical device, and laboratory regulation