90 Minute Webinar Video
Speaker: Donna Roscoe, Ph.D.
Scientific Reviewer
Office of In-Vitro Diagnostics
Office of Immunology and Hematology
FDA
What is the pre-IDE; Investigational
Device Exemption (IDE) Program?
* A free consultative service by the
review staff at the FDA
* A non binding agreement between FDA &
sponsor
* Results in a well prepared submission
* Results in a shortened review time
* Results in saving money and resources for
both the industry and the FDA
FDA Guidance and Best Practices for Going
Through the Pre-IDE Process
* Recognizing the importance of quality
pre-IDE submissions
* Introduction to the pre-IDE process
* Protocol proposal by sponsor
o Intended use statements
o Objectives of the clinical study
o Study design and testing
procedures
o Study results
* Review by FDA review team
* Meeting with sponsor
* Written feedback to sponsor
* Summary and examples
* Question & answer period
Cost
The cost to purchase the video recording is $395.
Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer. | 
