Farley D
FDA Consum. 1994 Jan-Feb;28(1):12-7.
Certain heart valves manufactured by Shiley, Inc., turned out to have increased fracture rates. Alerting doctors and patients to this problem has changed the way FDA expects manufacturers to communicate significant risks with medical devices.
施利公司生产的某些心脏瓣膜被证明出现了更高的断裂率。向医生和患者通报这一问题改变了美国食品药品监督管理局对制造商就医疗器械重大风险进行沟通的期望方式。
