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Health / Research / Pharmacology / Pharmaceutical industry / Investigational Device Exemption / Medicine / Clinical research / Food and Drug Administration


How to Put Together an IDE Application Lynn Henley, M.S., M.B.A. IDE and HDE Programs Center for Devices and Radiological Health FDA’s 2013 Clinical Investigator Training Course
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investigational device / medical devices / marketed device / /

Organization

FDA / HDE Programs Center for Devices / IDE / PMA HDE / /

Person

Lynn Henley / /

Position

FDAAA Clinical Investigator / purpose Clinical Investigator / Device requirements Clinical Investigator / Clinical Investigator / conducting investigations Clinical Investigator / Regulation Clinical Investigator / Emergency Use Compassionate Use Treatment Use Continued Access Clinical Investigator / informed consent Clinical Investigator / intended use Clinical Investigator / /

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