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IndustryTerm 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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