Medical Device Right to Repair Act.
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. Among other things, the law prohibits a person from conducting a home medical device retail facility business in this state unless the person has obtained a license from the department and sets forth standards for operating that facility. Existing law authorizes the department to waive any licensing requirements for a medical device retail facility when, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure.
This bill would enact the Medical Device Right to Repair Act, and would require an original manufacturer of powered medical equipment used in the treatment, monitoring, or diagnosis of a patient to provide documentation, parts, and tools used to inspect, diagnose, maintain, and repair powered medical equipment to an authorized repair provider on fair and reasonable terms, as defined. The bill would exempt from these requirements any trade secret information. The bill would subject a person who knowingly violates these provisions to specified civil penalties, and would authorize the Attorney General or a district attorney, county counsel, or city attorney to bring a civil action for this purpose.