Ansel Gary M, Jaff Michael R
Center for Critical Limb Care, Riverside Methodist Hospital, University of Toledo Medical School, Columbus, Ohio 43214, USA.
Catheter Cardiovasc Interv. 2008 Dec 1;72(7):998-1002. doi: 10.1002/ccd.21776.
Once a device is approved for sale in the United States by the Food and Drug Administration (FDA), it can legally be used by doctors to treat any condition a physician determines is medically appropriate. Based on postmarket published data and physician procedural experience, this may even become the standard of care when an alternative device either does not exist or is inferior in performance, even before FDA approval. This right of physicians to practice medicine without FDA approval is Federal law. The off-label use of medical devices for the treatment of peripheral vascular disease has recently become the latest target by groups with interests that have little to do with patient care. This interference has begun to negatively impact the latitude necessary for physicians to best treat their patients.
一旦一种医疗器械获得美国食品药品监督管理局（FDA）批准在美国销售，医生就可以合法地使用它来治疗任何经医生判定在医学上适用的病症。根据上市后公布的数据和医生的操作经验，即使在FDA批准之前，当不存在替代器械或替代器械性能较差时，这甚至可能成为护理标准。医生在未经FDA批准的情况下行医的这种权利是联邦法律规定的。医疗器械用于治疗外周血管疾病的非标签使用最近已成为一些与患者护理关系不大的利益集团的最新攻击目标。这种干预已开始对医生为患者提供最佳治疗所需的自由度产生负面影响。
