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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.

作者信息

Mihalko William M

机构信息

Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, University of Tennessee Health Science Center, Memphis, Tennessee.

出版信息

J Arthroplasty. 2015 Jun;30(6):919-22. doi: 10.1016/j.arth.2015.01.025. Epub 2015 Jan 23.

DOI:10.1016/j.arth.2015.01.025
PMID:25690754
Abstract
摘要

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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.
J Arthroplasty. 2015 Jun;30(6):919-22. doi: 10.1016/j.arth.2015.01.025. Epub 2015 Jan 23.
2
Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.根据联邦《食品、药品和化妆品法案》进行的药品和医疗器械出口:谢尔希案后美国食品药品监督管理局在解释上的显著变化。
Food Drug Law J. 2009;64(1):149-69.
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FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.美国食品药品监督管理局扩大上市后监管权限以监测并公布食品及消费品健康风险:在9·11后的监管环境中,需要程序保障措施来减少“透明度”政策带来的危害
Food Drug Law J. 2009;64(3):577-98.
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The FDA's role in medical device clinical studies of human subjects.美国食品药品监督管理局在人体受试者医疗器械临床研究中的作用。
J Neural Eng. 2005 Mar;2(1):S1-4. doi: 10.1088/1741-2560/2/1/001. Epub 2005 Feb 22.
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MD Comput. 1992 Mar-Apr;9(2):97-100.
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FDA's regulation of tanning beds: how much heat?美国食品药品监督管理局对晒黑床的监管:多少热量?
Food Drug Law J. 2011;66(1):25-46, i.
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General and plastic surgery devices; effective date of requirement for premarket approval of the silicone inflatable breast prosthesis. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule.普通外科和整形外科器械;硅酮充气式乳房假体上市前批准要求的生效日期。卫生与公众服务部(HHS),公共卫生服务局(PHS),食品药品监督管理局(FDA)。最终规则。
Fed Regist. 1999 Aug 19;64(160):45155-61.
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The Safe Medical Devices Act of 1990--FDA. Notice.1990年《安全医疗器械法案》——美国食品药品监督管理局。通知。
Fed Regist. 1991 Apr 5;56(66):14111-3.
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Scanning for higher profits. The FDA's plan to require bar codes on commonly used medical products will do more than improve patient safety.
Mod Healthc. 2003 Jun 16;33(24):6-7, 16, 1.

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JACC Basic Transl Sci. 2018 Aug 28;3(4):533-544. doi: 10.1016/j.jacbts.2018.06.006. eCollection 2018 Aug.
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Tapered modular fluted titanium stems for femoral fixation in revision total knee arthroplasty.用于翻修全膝关节置换术中股骨固定的锥形模块化带槽钛柄。
Arthroplast Today. 2017 Apr 21;4(1):3-9. doi: 10.1016/j.artd.2017.03.006. eCollection 2018 Mar.
3
Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.
可定制的骨肿瘤植入物:一家机构满足当前机构审查委员会和美国食品药品监督管理局要求的经验。
Springerplus. 2016 Jul 4;5(1):967. doi: 10.1186/s40064-016-2696-1. eCollection 2016.
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Going "social" to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access.通过“社交”途径获取实验性且可能挽救生命的治疗:对扩大获取途径的政策及在线患者维权环境的评估
BMC Med. 2016 Feb 2;14:17. doi: 10.1186/s12916-016-0568-8.