FDA Design Considerations for Devices Intended for Home Use
标准简介
Design Considerations for Devices Intended for Home Use[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Design Considerations for Devices Intended for Home Use[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 for Devices Intended for Home Use Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks. Throughout this guidance the term “you” refers to manufacturers as defined in 21 CFR 820.3(o). For convenience the definition is restated here: Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes, but is not limited to, those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. For additional information or questions about the FDA-recognized standards referenced in 1
this guidance document, please contact CDRH’s Standards Program. 1
Web site addresses for all hyperlinked material in this guidance document can be found in Appendix 1: List of References. 1
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