BiaCare is a manufacturer of medical products that are classified as United States Food and Drug Administration (FDA) Class I. All manufacturers of Class I products must register with the FDA and comply with all applicable regulations. BiaCare has been registered with the FDA since 2006 and in full compliance with all required regulations since 2006. You can prescribe BiaCare products with complete confidence knowing that they either meet, or in most cases exceed, minimum guidelines established by the FDA.