Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD, USA.
Br J Radiol. 2021 Oct 1;94(1126):20210373. doi: 10.1259/bjr.20210373. Epub 2021 May 14.
The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.
美国食品和药物管理局（FDA）半个世纪以来一直致力于将人们不必要的辐射暴露降至最低。医用 X 射线成像设备的制造商是这一努力的重要合作伙伴。FDA 根据其电子产品法规和医疗器械法规对医用 X 射线成像设备进行监管。FDA 还发布指导文件，这些文件代表了 FDA 对某个主题的最新想法，并提供了一种建议或推荐的方法，以满足法规或法规的要求。FDA 鼓励制造商开发符合自愿共识标准的医疗器械。使用这些标准是 FDA 确保在美国销售的所有医疗器械符合安全性和有效性要求的系统的核心要素。FDA 工作人员积极参与这些标准的制定和维护，经常提出或引入新的安全和剂量管理要求。使用自愿共识标准减少了评估上市前提交所需的时间，并减轻了制造商的负担。FDA 通过与行业团体的会议、公开会议、公开沟通以及制定自愿共识标准，与行业和其他利益相关者进行互动。在这些互动中，FDA 工作人员引入了提高这些设备安全性的新概念，并为专业组织的类似举措提供支持。FDA 与所有利益相关者合作，以实现保护和促进公众健康的使命。
