Audio Conference: Understanding the Pre-IDE Process

Working with the FDA to Fully Understand the Pre-IDE Process, Including Submission and Review
Thursday February 5th, 2009

90 Minute Audio Conference

2PM Eastern Standard Time

 

 

Speaker:

Sousan S. Altaie, Ph.D.
Scientific Policy Advisor
Office of In-Vitro Diagnostics
FDA

 

Regulatory approval of any medical device is paramount to the commercial success of that product and the company itself in many cases.  In-Vitro Diagnostics are similar and are being encouraged to utilize the Pre-IDE process that the FDA has put into place specifically for their technology.  While pharmaceutical and medical device companies have pre-determined approval categories and pathways (510(k), PMA, NDA), IVD companies often have a more difficult time understanding which regulatory path fits their device and the impact this path has on the clinical evidence and utility data they will have to submit to OIVD.

 

What is the pre–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
  • Intended use statements
  • Objectives of the clinical study
  • Study design and testing procedures
  • Study results
• Review by FDA review team
• Meeting with sponsor
• Written feedback to sponsor
• Summary and examples
• Question & answer period
  

Speaker Biography:

Dr. Sousan Altaie is the Scientific Policy Advisor for the Office of In Vitro Diagnostic Devices and is actively working as a member of the Global Harmonization Task Force (GHTF) and International Standards Organization (ISO) working groups. She was appointed the CDRH Critical Path Coordinator in 2004 and is actively involved in the Agency's Critical Path initiative. She is the author of many peer reviewed articles.

 

 

To Register Click Here

 

For additional information contact:

Paul Hernandez
312.602.9684
phernandez@q1productions.com