The Successful IDE - May, 2007

The Successful IDE is Part 2 in a Four part Series:
Part 3:The Successful 510k

Part 4:The Successful PMA

 

Objective:
This part of the series will discuss the preparation of Investigational Device Exemption Applications (IDEs) that will be: approvedby FDA, provide valid scientific evidence, and support the approval of 510(k)s and PMAs. 

    

You will learn from Part 2: 

• How to approach FDA with clinical testing plans
• The difference between 510(k) and PMA trials
• What is in an IDE application
• What constitutes valid scientific evidence
• Labeling factors that influence study designs
• The characteristics of well controlled investigations
• Pivotal study design options
• Control options
• Selection of study endpoints

Who Should Attend Part 2:
This eConference is designed for regulatory and clinical affairs specialists who help design clinical trials that will be used to gather data for supporting FDA marketing applications, and for those specialists who will submit IDEs to FDA.  

   

Presenter:
Ms. Patsy J. Trisler, J.D., RAC. and former FDA reviewer, is an independent consultant providing services related to FDA regulatory requirements and clinical compliance issues, primarily to the medical device industry. Ms. Trisler can be reached at patsy.trisler@verizon.net.

 

The purchase is $407 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.