HR 5662 United States House · 118th Congress

Medical Device Recall Improvement Act

This bill requires medical device manufacturers to send electronic recall notifications containing specific details like device identifiers, the reason for recall, and patient risks. It specifically mandates that manufacturers include patient risk information and instructions for healthcare providers to share this with patients for high-risk devices (e.g., implanted, life-sustaining, or used in children). The FDA must create a public database of all recall information, and manufacturers face penalties for failing to submit required electronic notifications or patient notices. These changes apply directly to device manufacturers, healthcare facilities, and patients affected by recalls of certain high-risk medical devices.
Bill status in committee 1 of 4 stages cleared
Introduction
Sep 2023
Committee Review
Floor Vote
President
Introduced Sep 21, 2023 Last action Sep 22, 2023
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Full legislative history

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Total actions
3
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0
Committee
2
Sep 22, 2023
House · Referred to committee
Referred to the Subcommittee on Health.
Sep 21, 2023
House · Referred to committee
Referred to the House Committee on Energy and Commerce.
Sep 21, 2023
House · Introduced
Introduced in House
1 primary · 1 co-sponsor

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