Can the sponsor get a waiver from certain IDE requirements?
Under ยง 812.10, a sponsor may request FDA to waive any requirement of the IDE regulation. A waiver request with supporting documentation may be submitted as part of an application or separately. FDA may, by letter, grant a waiver of any requirement that is not required by the FD&C Act and that is unnecessary to protect the human subject by providing a letter to the sponsor outlining the waiver.
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