Investigator Manual

Chapter 14 - Flowchart Diagram

1. Does my study contain a medical device?
   1. No

      • No further considerations.  FDA device regulations do not apply.

   2. Yes
      • Go to next list item

2. Is the medical device an object of investigation in the study?

   1. No

      • No further considerations.  FDA device regulations do not apply.

   2. Yes
      • Go to next list item

3. Does my investigational device meet the requirements to be considered IDE Exempt?

   1. Yes

      • Your device is IDE Exempt.  Indicate in the protocol why your device is exempt from the IDE requirements.  Note that your protocol is still considered FDA regulated.

   2.  No
      • Go to next list item

4. Does my device pose a Significant Risk to participants as defined by the FDA?

   1. No

      • Your device is a Non-Significant Risk device.  Indicate in the protocol why your device does not pose a significant risk to participants.

   2. Yes

      • Your device is a Significant Risk device that is not IND Exempt.  You are required to submit an IDE application to the FDA for approval.  This approval needs to be submitted for IRB review.