Today's Law As Amended


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AB-2058 Devices:disclosures.(2023-2024)



As Amends the Law Today


SECTION 1.

 Chapter 7.6 (commencing with Section 111823) is added to Part 5 of Division 104 of the Health and Safety Code, to read:

CHAPTER  7.6. Device Disclosures
111823.
 (a) A device that collects or analyzes information originating from a physiological source, including, but not limited to, heartbeat, blood pressure, body temperature, or blood oxygen, and is not subject to regulation under the federal act (21 U.S.C. Sec. 301 et seq.), or any other federal law or regulation, including the Medical Device Amendments of 1976 (21 U.S.C. Sec. 360c et seq.), shall have a legible disclosure affixed on the product, packaging, or within informational materials included within the packaging for the device, or within user instructions, or a combination thereof, that includes limitations known by the manufacturer on the effectiveness of the device for the device’s intended population because of certain characteristics of the person using the device or of the person on which the device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.
(b) This chapter shall become operative on January 1, 2027.
SEC. 2.
 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.