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CA AB2058
Bill
Status
9/29/2024
Primary Sponsor
Akilah Weber Pierson
Click for details
AI Summary
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Requires devices that collect or analyze physiological information (such as heartbeat, blood pressure, body temperature, or blood oxygen) to include legible disclosures about known limitations in effectiveness for specific populations, effective January 1, 2027.
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Applies only to devices not regulated under federal laws, including the Federal Food, Drug, and Cosmetic Act and the Medical Device Amendments of 1976.
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Disclosures must address effectiveness limitations based on characteristics including age, color, disability, ethnicity, gender, or race, and may be placed on the product, packaging, informational materials, or user instructions.
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Expands the scope of violations under the Sherman Food, Drug, and Cosmetic Law, making non-compliance a crime.
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Specifies that no state reimbursement is required for local agencies or school districts under Article XIII B of the California Constitution.
Legislative Description
Devices:disclosures.
Last Action
Vetoed by Governor.
9/29/2024