HR 1539 United States House · 119th Congress

Medical Device Electronic Labeling Act

HR 1539, the Medical Device Electronic Labeling Act, allows medical device manufacturers to provide required product labeling exclusively through electronic means, rather than physical copies. This change directly affects device manufacturers, healthcare providers, and patients who access device information. Key provisions require that electronic labeling be readily accessible online, manufacturers must provide paper copies upon request without cost, and the physical device label must still include essential safety and usage information. The bill does not alter existing safety standards but updates how labeling is delivered, with the FDA retaining authority to issue additional requirements via Federal Register notices for specific devices.
Bill status in committee 1 of 4 stages cleared
Introduction
Feb 2025
Committee Review
Floor Vote
President
Introduced Feb 24, 2025 Last action Feb 24, 2025
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Total actions
2
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0
Committee
1
Feb 24, 2025
Committee
Referred to the House Committee on Energy and Commerce.
lower
Feb 24, 2025
Introduced
Introduced in House
lower
1 primary · 7 co-sponsors

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