FDA issues long-awaited update to Pre-IDE guidance: New draft guidance on Pre-Submission program for medical devices releasedJonathan S. KahanGerard J. Prud'hommeJohn J. SmithKristin M. Zielinski
近日,FDA发布了《循环肿瘤DNA用于治疗性实体瘤药物开发的行业指南(Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development Guidance for Industry)》,旨在为那些计划在新药申请(IND)下进行的临床试验中使用循环肿瘤DNA (ctDNA)作为生物标志物的药物研发申办者提供指导,和/或支持用于治疗早期实体...
该指南草案正式通过后将取代2023年6月2号发布的“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”和1998年2月19日发布的““Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent
FDA指导原则-有源.pdf,FDA-指导原则——有源 (译文:该中文版是非正式版本,仅供参考。英文版则是FDA官方文件,具有法律解释权) 序号 中文翻译件文件名称 原文文件名称 中文文件下载 原文文件下载 1 磨皮术设备指南 Guidance for Dermabrasion Devices 下载 下载 2 裂隙灯
此外,FDA也在前面提到的发文中指出:“Although the ICH document was written for studies of pharmacuticals,sections of the guidance address study issues common to all investigational products.Thus,these sections of the ICH GCP provide a useful ref...
in Medical Devices: Quality System Considerations and Content of Premarket Submissions—Guidance for ...
[6] FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and FDA Staff [EB/OL]. (2023-06- 02) [2023-08-23]. https://www. fda. gov/media/114034/ download. [7] FDA. Controlled Correspondence Related to Generic Drug ...
含现有(OTS)软件的网络化医疗设备的CybersecurityforNetworkedMedicalDevices 25下载下载 网络安全ContainingOff-the-Shelf(OTS)Software 报告评价诊断检验的研究结果的统计学StatisticalGuidanceonReportingResultsfrom 26下载下载 指导原则StudiesEvaluatingDiagnosticTests ...
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.Pre-submission的适用对象 · 510(K)· PMA · De Novo request · 临床实验器械豁免IDE 2. Pre-submission的积极作用 Pre-submission途径，便于FDA提前审核临床和非临床研究的方案，以及其他关键信息，申请人在获得 FDA 反馈后，可在研究方案中尽可能地吸纳FDA意见。Pre-submission提交，既有利于提高之后正式递交...