The United States Food and Drug Administration (FDA) places considerable importance on the validation of software contained in and used to design, develop, or manufacture medical devices. This article discusses a recently published final FDA guidance document on software validation and the reasons for...
The FDA hasissued draft guidance with recommendations for submitting medical devices that include AI-enabled software functions. “The recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle (TPLC),” the FDA said. “To support ...
原文来自:盛德律所 “One Step Forward, Two Steps Back: FDA’s Final Guidance on Clinical Decision Software Raises More Questions Than Answers” 作者:Coleen Klasmeier, Jeffrey M. Senger, Jaclyn G. Fonteyne, Yuzhi Hu 编译:识林-椒
FDA指导文件-医疗设备中现成软件的使用Off-The-Shelf-Guidance_0.pdf,Contains Nonbinding Recommendations Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 11, 2023. Document o
·医疗器械患者标识指南Guidanceon Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers ·器械建议的标识要求Labeling requirements from Device Advice FDA认可共识标准：四、FDA审核主体与要求 1.FDA的CDRH及其它中心对各种上市前申请进行审核，人因上市前评估组（Human Factors Premarket ...
研究点推荐 FDA Draft Guidance Software as a Medical Device 站内活动 0关于我们 百度学术集成海量学术资源,融合人工智能、深度学习、大数据分析等技术,为科研工作者提供全面快捷的学术服务。在这里我们保持学习的态度,不忘初心,砥砺前行。了解更多>> 友情链接 ...
In December, FDA issued two draft guidances, Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, meant to clarify the agency’s role ...
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data ...
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems Document issued on July 27, 2006 For questions regarding this document, contact Elizabeth Stafford at 301-796-6184 or by e-mail at elizabeth.stafford@fda.hhs.gov. U.S...
2022年9月12日星期一，FDA发布最新的指南草案：生产和质量系统软件的计算机软件保证（Computer Software ...