Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. Existing law authorizes the department to establish performance standards for devices designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device.
This bill would require, beginning January 1, 2027, a device that collects or analyzes information originating from a physiological source and is not subject to specified federal regulations, to have a legible disclosure on the product, the packaging, or within informational materials included with the
packaging for the device, or within user instructions, 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. By expanding the scope of a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.