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- 12:06, 9 November 2023 Editor iHTS talk contribs created page Investigational device exemption (IDE) (Created page with "A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness. '''Note:''' The data thus collected may be used subsequently in a premarketing approval application.# [http://htaglossary.net/investigational-device-exemption-(IDE)]") Tag: Visual edit