Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Sponsors of IDEs are also exempt from the Quality System (QS) Regulation except for the requirements for design control.
A commercial sponsor of a significant risk device study must submit a complete IDE application to FDA.
The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.