FDA APPROVAL PROCESS
FOR MEDICAL DEVICES

Conference Date: 15-16 Jan 2009
Conference Ref: N1-8209
Fee: £1100 + VAT
Venue: The Rembrandt Hotel, London

BENEFITS IN ATTENDING

This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products.  Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved.  Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents.  Information on maintaining ongoing relationships with the FDA will also be discussed.  Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval.

Upon completion of this seminar, participants will:

• Understand the FDA medical device approval system
• Know what is required for an Investigational Device Exemption (IDE)
• Learn the contents of a Post-Market Approval (PMA)
• Discover what to include in an annual report