IDE Modifications

Changes in investigational plan that require prior approval

A sponsor must obtain approval of a supplemental application and IRB approval prior to implementing a change to an investigational plan except in situations described below. If a sponsor intends to conduct an investigation that involves an exception to informed consent the sponsor must submit a separate investigational device exemption (IDE) application.

• change in indication,
• change in type or nature of study control
• change in primary endpoint,
• change in method of statistical evaluation, and
• early termination of the study (except for reasons related to patient safety).

Changes that do not require prior FDA approval

The sponsor of an IDE may modify the device and/or clinical protocol without approval of a new application or supplemental applications if the modifications meet certain criteria. The notice must be provided to FDA within 5 working days of making the change.

1. Emergency Use
   FDA approval of a supplement does not apply in the case of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency.


2. Certain Developmental Changes
   An FDA approved supplement is not required for developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or basic principles of operation and that are made in response to information gathered during the course of an investigation.