new indications for use for the device.labeling changes.the use of a different facility or establishment to manufacture, process, or package the device.changes in the sterilization procedures.changes in packaging. changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device. extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that has not been approved by FDA