FDA Clinical Decision Support Software Draft
标准简介
Clinical Decision Support Software Draft[附网盘链接]是FDA于不久前发布的FDA标准，适用于US。标准截图
![Clinical Decision Support Software Draft[附网盘链接]](/img/20210914103618935qw.jpg)
标准文档说明
标准文档类型为Clinical Decision Support Software Draft[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
Draft – Not for Implementation
1 Clinical Decision Support Software 2
3 Draft Guidance for Industry and
4 Food and Drug Administration Staff
5
6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 8 and is not binding on FDA or the public. You can use an alternative approach if it satisfies 9 the requirements of the applicable statutes and regulations. To discuss an alternative 10 approach, contact the FDA staff or Office responsible for this guidance as listed on the title 11 page. 12 I. Introduction
13 The Food and Drug Administration (FDA) has long regulated software that meets the definition 14 of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 15 including software that is intended to provide decision support for the diagnosis, treatment, 16 prevention, cure, or mitigation of diseases or other conditions (often referred to as clinical 17 decision support software). This guidance provides clarity on the scope of FDA’s oversight of 18 clinical decision support software intended for health care professionals, patients, or caregivers.
19 FDA recognizes that the term “clinical decision support” or “CDS” is used broadly and in 20 different ways, depending on the context. CDS provides health care professionals (HCPs) and 21 patients with knowledge and person-specific information, intelligently filtered or presented at 1
22 appropriate times, to enhance health and health care. In the Food and Drug Administration 23 Safety and Innovation Act (FDASIA) Health IT Report of 2014, CDS is described as a variety of 24 tools including, but not limited to: computerized alerts and reminders for providers and patients; 25 clinical guidelines; condition-specific order sets; focused patient data reports and summaries; 2
26 documentation templates; diagnostic support; and contextually relevant reference information.
27 For the purposes of this guidance, the term “CDS” is used to refer to functions that are either 28 Device CDS or Non-Device CDS. FDA uses criteria from the 21st Century Cures Act (Cures 29 Act) to determine if a software function is Device CDS or Non-Device CDS (see Section III). 30 The purpose of this guidance is to describe FDA’s regulatory approach to CDS software 31 functions. The agency’s approach includes recent changes to the FD&C Act made by the Cures 32 Act, which amended section 520 and excludes certain software functions from the device 33 definition. This guidance clarifies the types of CDS software functions that: (1) do not meet the 1
See Office of the National Coordinator for Health Information Technology, “What is Clinical Decision Support (CDS)?” at https://www.healthit.gov/topic/safety/clinical-decision-support. 2
FDASIA Health IT Report, April 2014, available at https://www.fda.gov/about-fda/cdrh-reports/fdasia-health-it-
report.
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