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Investigational device exemption (IDE)
Clinical study performed to collect clinical data on a device to support approval of a marketing application. Approval of an IDE study does not mean approval to market the implant. The status of a device in an IDE study is investigational.
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- Part of Speech: noun
- Synonym(s):
- Blossary:
- Industry/Domain: Beauty
- Category: Breast implant
- Company: U.S. FDA
- Product:
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