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美国食品和药品管理局发布加强医疗设备安全与创新管理的最新举措

FDA Commissioner Scott Gottlieb


    自2018年4月17日生效的、由美国食品和药品管理局发布的《关于加强医疗设备安全与创新管理的最新举措的声明》中指出，医疗器械创新对健康促进的贡献已史无前例，其中所涉及的材料学、数字技术和高级制造三个领域正面临不均衡的发展现状。尽管去年获FDA批准的创新型准入器械数量达到了历史新高，但因缺乏排除隐患所需的临床证据而亟需FDA采用新的监管手段加以规范。


    FDA此次推出的“行动计划”Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health”主要涉及五个领域：


  1. 1. 在美国建立健全医疗设备患者安全网络;
  2. 2. 探索高效、与时俱进的现代化准入后管理办法;
  3. 3. 鼓励发展更高安全级别的创新;
  4. 4. 推进医疗器械网络安全;
  5. 5. 重新整合FDA设备和放射卫生中心（FDA’s Center for Devices and Radiological Health）的准入前后管理分工并进一步推动产品全生命周期(Total Product Life Cycle, TPLC)设备安全管理法。


文献

1. Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation

2. Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health


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