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
数据完整性修复 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 ...
(仅供参考)FDA Software Validation软件验证指南 General Principles of Software Validation; 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, 2002 This document supersedes the draft document, "General Principles of Software ...
FDA software validation is the process of confirming that software specifications meet user needs and intended uses through examination and the provision of objective evidence.
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...
Software validation methods The FDA’s guidance and requirements can seem overwhelming — but the task of following them can be simplified to not only stay compliant, but to help your business, as well. Most validation projects follow the same basic format, known as the “4Q Lifecycle Model...
Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance Topics Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premar...
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation athttps://www.fda.gov/media/71021/download. 请参阅FDA的指导性文件《工艺验证:一般原则和惯例》,以获取FDA关于工艺验证适当要...
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 The draft guidance states that if a “device has been relatively unchanged since FDA’s prior authorization and a new PCCP is proposed, FDA would focus its re...
The US Food and Drug Administration (FDA) has released two final guidance documents: Deciding When to Submit a 510(k) for a Change to an Existing Device, which applies to medical device changes broadly, and Deciding When to Submit a 510(h) for a Software Change to an Existing Device, wh...