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
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...
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 ...
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
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 ...
Software Contained in Medical Devices” (/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u cm089543.htm) and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” (/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u cm077812....
[1] FDA, Software Development Activities, 1987. [2] FDA, Guideline for the Monitoring of Clinical Investigations, 1988. [3] FDA, Guidance for Industry: Good Target Animal Practices: Clinical Investigators and Monitors, 1997. [4] FDA, ...
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 ...
See FDA’s guidance document Data Integrity and Compliance With Drug CGMP您的质量体系无法充分确保数据的准确性和完整性,以支持您生产的药物的安全性、有效性和质量。请参阅FDA的指导文件《药物CGMP的数据完整性和合规性》,了解 https://www.fda.gov/media/97005/download 建立和遵循CGMP合规数据完整性实践的...
This information will help inform further FDA guidance on the consistency of LOINC codes associated with laboratory devices.提交LOINC代码时,您应该: 1) 继续以 CDISC SDTM 格式提交实验室数据,使用 CDISC 实验室术语以及给定实验室测试的 LOINC 代码。 2) 在 SDTM LB 域的 LBLOINC 字段中输入 LOINC 代码,...