The registrant of a device shall immediately notify the director of any proposed change to the device including, but not limited to, labeling composition, configuration method of application, and use of the device. The director shall determine whether the changes require the director’s approval before the changed device may be manufactured for sale, advertised, delivered or otherwise provided, offered for sale or lease, sold, leased, possessed, or used in this state. The director shall notify the registrant of this determination.