The department may establish performance standards for devices, that shall be 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. However, if a performance standard is established for a device pursuant to Section 514 of the federal act (21 U.S.C. Sec. 360d) or Section 521 of the federal act (21 U.S.C. Sec. 360k), it shall be the performance standard of this state for device.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
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