Investigational device exemption (IDE): Difference between revisions
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)]") |
Editor iHTS (talk | contribs) No edit summary |
||
| Line 1: | Line 1: | ||
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. | 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 (PMA)|premarketing approval application]]. | '''Note:''' The data thus collected may be used subsequently in a [[Premarketing approval application (PMA)|premarketing approval application]]. | ||
[http://htaglossary.net/investigational-device-exemption-(IDE)] | [http://htaglossary.net/investigational-device-exemption-(IDE)] | ||
Revision as of 12:06, 9 November 2023
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.