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来源：百度知道 编辑：UC知道 时间：2024/05/17 18:49:11
because of the substantial penalties for failure to register as a medical device manufacturer no manufacturer who sells device connecting network software can assume that they are not required to file as a device manufacturer.if in doubt ,the FDA should be consulted .At a minimum,competent counsel with expertise in FDA regulated softwareshould be consulted to determine the status of any given software product,prior to accepting the software.[6] Hospitals and other users of medical devices face substantial liability for defective devices.[12] The failure to confirm FDA registration of the device might subject the Institution to punitive damages.The FDA is aware of and reponding to the failure of software vendors to registerunder the act .Failure to register can lead to civil and criminal penalties. Further, the structure of the new Act and the new approach to enforcement may lead to targeting of unregistered manufacturers.In particular,the 1990 Act gives the FDA many more tools to pe

局发现法令难运转的。为了应付负荷，食品药物管理局适应了行为， 510(k) 程序的一个较小区段, 赞同 95% 的所有医学的装置。行为的这一个区段藉由祖父对 pre 1976个装置是 " 实质上相等 " 的装置已经被设计如一个变迁的区段 , 而且操作。本质上 510(k) 程序包括对 manufacturers's 的意图食品药物管理局的一个 premarket 通知在市场上销售一种产品。经过这一个程序拿制造业者必须宣称没有东西新奇的有关他们的产品事, ie 产品的那一个每件事物只是已经存在的装置重做人在～之前 1976.
第 4 段： 1990 行为改变食物和药行为 510(k) s 的治疗使一致他们到食品药物管理局练习。statule 明确地赞同食品药物管理局方式, 但是由于加强报告和厉行机制。变化尤其对软件网络是重要的, 因为如此很少他们在 1976 它可以说难以宣称他们实质上是相等的 pre 改善装置中存在