Investigational device exemption (IDE)
Revision as of 12:06, 9 November 2023 by Editor iHTS (talk | contribs) (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)]")
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.#