IDE Application - Grounds for Clinical Hold

FDA may prohibit the sponsor of an investigation from conducting the investigation (referred to ‘clinical hold’) if an approved IDE represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved.

The sponsor of an IDE that is on clinical hold may request by writing to FDA to remove the clinical hold. Any such request shall include sufficient information to support the removal of such clinical hold.