FDA Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
标准简介
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices[附网盘链接]是Food&Drug Administration于之前发布的FDA标准，适用于US。标准截图
![Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices[附网盘链接]](/img/20210914103712x15zo.jpg)
标准文档说明
标准文档类型为Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Design Considerations and Pre-
market Submission Recommendations for Interoperable Medical Devices Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important. Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices as well as other technology offers the potential to increase efficiency in patient care. FDA intends to promote the development and availability of safe and effective interoperable medical devices. FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.” 1
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