Harper Courtney C
Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Maryland 20850, USA.
J Diabetes Sci Technol. 2009 Jul 1;3(4):739-42. doi: 10.1177/193229680900300420.
Personalized medicine has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The U.S. Food and Drug Administration (FDA) is interested in promoting personalized medicine, whenever appropriate, to protect and promote the public health. The ability to better diagnose, screen, and manage patients with diabetes in order to individualize care should lead to better health outcomes and a large benefit to public health. This article describes FDA regulatory considerations for devices intended for use as personalized medicine tools for the diagnosis and treatment of patients with diabetes.
个性化医疗因其改善患者护理和优化治疗策略的潜力，已成为备受关注的话题。美国食品药品监督管理局（FDA）在适当的时候有意推动个性化医疗，以保护和促进公众健康。能够更好地诊断、筛查和管理糖尿病患者，从而实现个性化护理，应能带来更好的健康结果，并对公众健康大有裨益。本文介绍了FDA对用作糖尿病患者诊断和治疗的个性化医疗工具的器械的监管考量。
