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FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff

机译：FDa关于研究设备豁免的决定临床调查：赞助商指南，机构审查委员会和食品药品管理局工作人员

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FDA seeks to encourage medical device research and innovation to address important clinical needs and improve patient care. In many cases, device development and evaluation include clinical investigation. This guidance document has been developed to facilitate the initiation of clinical investigations to evaluate medical devices under FDAs Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.

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年度 2014
页码 1-19
总页数 19
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Center for Devices and Radiological Health(CDRH); Pre-market approval;

机译：器械和放射健康中心（CDRH）;上市前批准;

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1. The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator. [J] . Pritchard WF Jr, Abel DB, Karanian JW Journal of vascular surgery . 1999,第3期

机译：美国食品和药物管理局的研究器械豁免（IDE）和心血管器械的临床研究：供研究人员参考的信息。
2. Understanding food and drug administration regulatory requirements for an investigational device exemption for sponsor-investigators [J] . HolbeinM.E.B., BerglundJ.P. Journal of investigative medicine . 2012,第7期

机译：理解食品和药物管理局对申办者研究人员豁免研究器械的监管要求
3. Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study [J] . Shetty Yashashn C., Saiyed Aafreen A. Journal of medical ethics . 2015,第5期

机译：美国食品和药物管理局向临床研究人员，机构审查委员会和发起人发出的警告信的分析：一项回顾性研究
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. Managing clinical investigator compliance to ensure Food and Drug Administration (FDA) inspection readiness. [D] . Yadlapalli, Sowmya. 2011

机译：管理临床研究人员的依从性，以确保食品药品监督管理局（FDA）的检查准备就绪。
6. Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators [O] . M. E. Blair Holbein, Jelena Petrovic Berglund -1

机译：了解资助者调查人员的调查设备豁免（IDE）的FDA监管要求
7. The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: Information for the investigator [O] . Pritchard William F., Abel Dorothy B., Karanian John W. 1999

机译：美国食品药品监督管理局的研究器械豁免（IDE）和心血管器械的临床研究：研究人员的信息
8. Guidance for FDA Reviews and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) [R] . 2008

机译：FDa评审和赞助商指南：化学，制造和控制的内容和评论（CmC）人类基因治疗信息研究新药申请（INDs）

FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff

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