How Do I Get What I Need? Navigating the FDA's Custom, Compassionate Use, and HDE Pathways for Medical Devices and Implants

Mihalko William M.

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How Do I Get What I Need? Navigating the FDA's Custom, Compassionate Use, and HDE Pathways for Medical Devices and Implants

机译：如何获得所需的东西？浏览FDA针对医疗设备和植入物的习惯，同情使用和HDE途径

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来源
《The Journal of arthroplasty》 |2015年第6期|共4页
作者
Mihalko William M.;
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正文语种 eng
中图分类骨科学（运动系疾病、矫形外科学）;
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入库时间 2022-08-18 18:15:19

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1. How Do I Get What I Need? Navigating the FDA's Custom, Compassionate Use, and HDE Pathways for Medical Devices and Implants [J] . Mihalko William M. The Journal of arthroplasty . 2015,第6期

机译：如何获得所需的东西？浏览FDA针对医疗设备和植入物的习惯，同情使用和HDE途径
2. Mass customization of medical devices and implants: state of the art and future directions [J] . K. W. DALGARNO, J. H. PALLARI, J. WOODBURN, Virtual and Physical Prototyping . 2006,第3期

机译：医疗设备和植入物的大规模定制：最新技术和未来方向
3. Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation : Current Directions in Biomedical Engineering [J] . Mareike Schonhoff, Astrid Heinze, Juliette Carrillo, Current Directions in Biomedical Engineering . 2019,第1期

机译：根据新的《欧洲医疗器械法规》开发和制造定制植入物：生物医学工程的最新方向
4. Microelectronic Packaging for Medical and Hi-Rel Devices Custom Integrated Circuit Design Enables Miniature Implantable Medical Devices - (PPT) [C] . Andy Kelly Advanced Technology Workshop and Tabletop Exhibits on Microelectronic Packaging for Medical and High Reliability Devices . 2013

机译：用于医疗和高级设备的微电子包装定制集成电路设计可实现微型植入式医疗设备 - （PPT）
5. Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products =Prácticas de gestión de proyectos y factores clave para el exito en FDA validaciones de factores humanos de dispositivos [D] . Rojas, KM. 2020

机译：项目管理实践和FDA人类因素成功的关键因素医疗设备和组合产品的验证= FDA人类因素验证设备的项目管理和因素管理实践
6. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways 1979-2012 [O] . Benjamin N. Rome, Daniel B. Kramer, Aaron S. Kesselheim -1

机译：FDA通过原始和补充上市前批准途径对心脏植入式电子设备的批准1979-2012年
7. The FDA De Novo medical device pathway, patents and anticompetition [O] . Jacob S. Sherkow, Mateo Aboy 2020

机译：FDA de Novo医疗器械途径，专利和防抱
8. Medical Devices: FDA's Approval of Four Temporomandibular Joint Implants [R] . 2007

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How Do I Get What I Need? Navigating the FDA's Custom, Compassionate Use, and HDE Pathways for Medical Devices and Implants

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