参考文献 [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...
On Jan. 7, 2025, the FDA issued itsdraft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” In its latest draft guidance on medical devices, the FDA provides recommendations on the documentation and information that should...
13.PreapprovalInspection Guide for Laboratory Analysts, 3/91 14.SoftwareDevelopment Activities Technical Report, 7/87 15.InterimGuide to Inspection of Validation of Filters for Sterilizing Liquids, 1995 16.ORAStability Guidance for Preapproval Inspections, 3/92 17.Inspectionof Bulk Chemical Substances, ...
Key words: Food and Drug Administration (FDA); drug; biological product; device; decentralized clinical trial (DCT); guidance 美国食品药品管理局(FDA)于 2023 年 5 月发 布了"药物 ,生物制品和器械去中心化临床试验供 企业 ,研究者和其他利益相关者用的指导原则草 案"[1].该指导原则草案提出了对药物...
While a PCCP can address many types of post-market device changes, FDA specifically recognizes that software development is an iterative process, and software developers continually try to improve and update devices. Therefore, this guidance builds on FDA’s commitment to “develop and apply innovativ...
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 documentData Integrity and Compliance With Drug CGMPfor guidance on est...
“The recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle (TPLC),” the FDA said. “To support the development of appropriate documentation for FDA’s assessment of the device, this draft guidance also proposes recommendatio...
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
1、General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff软件验证的基本原理;企业和FDA人员的最终指导准则Document issued on发布日期: January 11, 2002This document supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.本...
Any modification to an authorized PCCP requires resubmission of the full marketing submissionalong with the modified PCCP. The draft guidance states that if a “device has been relatively unchanged since FDA’s prior authorization and a new PCCP is proposed, FDA would focus its re...