Težak Živana, Kondratovich Marina V, Mansfield Elizabeth
Personalized Medicine Staff, Office of In Vitro Diagnostic Device Evaluation & Safety, Center for Devices & Radiological Health, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
Per Med. 2010 Sep;7(5):517-530. doi: 10.2217/pme.10.53.
Personalized medicine has captured the attention of the public, including patients, healthcare providers, scientists, medical product manufacturers and many others. The US FDA will evaluate many of the products that will allow personalized medicine to be successfully implemented in the USA. This article addresses the FDA's approach to regulation of one component of personalized medicine, in vitro diagnostic devices. It also describes the FDA's efforts to integrate the various medical product regulatory authorities provided by Congress in the Federal Food, Drug and Cosmetic Act to develop effective mechanisms for oversight of medical products used to personalize treatment. Finally, it presents some of the current challenges in in vitro diagnostics oversight that may be of interest for personalized medicine.
个性化医疗已经引起了公众的关注，其中包括患者、医疗服务提供者、科学家、医疗产品制造商以及许多其他群体。美国食品药品监督管理局（FDA）将对许多产品进行评估，这些产品将使个性化医疗在美国得以成功实施。本文探讨了FDA对个性化医疗的一个组成部分——体外诊断设备的监管方法。它还描述了FDA为整合国会在《联邦食品、药品和化妆品法案》中提供的各种医疗产品监管机构所做的努力，以建立有效的机制来监督用于个性化治疗的医疗产品。最后，本文介绍了体外诊断监管方面目前存在的一些挑战，这些挑战可能与个性化医疗相关。
