Humanitarians, Compassion, and the Food and Drug Administration: Guidance for the Practitioner

References

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FDA Guidance—Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry Document issued on July 12,2001 . Available at: http://www.fda.gov/cdrh/ode/guidance/1668.html
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Kaplan AV, Harvey ED, Kuntz RE, et al. Humanitarian Use Devices/Humanitarian Device Exemptions in cardiovascular medicine. Circulation 2005;112:2883–86
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Kelly ME, Furlan AJ, Fiorella D. Recanalization of an acute middle cerebral artery occlusion using a self-expanding, reconstrainable, intracranial microstent as a temporary endovascular bypass. Stroke 2008;39:1770–73
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Turk AS, Levy EI, Albuquerque FC, et al. Influence of patient age and stenosis location on Wingspan in-stent restenosis. AJNR Am J Neuroradiol 2008;29:23–7
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