IDE Submissions Workshop

February 27, 2013 — Sheraton Crystal City, Arlington, VA

Overview |  Agenda |  Speakers |  Logistics |  Fees


FDA Staff Leaders and Industry Experts at this interactive workshop will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption is required, how to compile effective investigational device exemption applications, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre- investigational device exemption meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices.

Please contact for Group Discounts
(discount does not apply to EGCC, Government, or Non-Profit Organizations)


“An excellent workshop. My firm is new to the FDA regulated market place and this course provided us with background and current opinions, as well as opportunity to network with the driving forces in the industry.”

"This IDE seminar was very informative, particularly for someone new to Reg Affairs such as myself. Most of the speakers were really engaging and were good at keeping my interest, as well."


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Lynn Henley, MS, MBA, Biologist, IDE & HDE Programs, FDA/CDRH
Carol Simmons, MS, RN, FNP, Consumer Safety Officer, CDRH/FDA
Tony Blank, Cofounder and Senior Advisor, Barton & Blank, LLC
Christine L. Brauer, Ph.D., Regulatory Affairs Consultant, Brauer Device Consultants, LLC
Michael Morton, Senior Director, Regulatory Affairs, Medtronic

Hotel & Meeting Logistics

Sheraton Crystal City
1800 Jefferson Davis Highway
Arlington, VA  22202
Reservations:  1-888-627-8209 (Reference AdvaMed when making reservations)
or online by Clicking Here
Room rate:  $195.00
Rate available 3 days prior/post meeting date based on hotel availability
Hotel cut-off date for reservations:  2/3/13

Registration Fees

AdvaMed Member Registration: $995.00
AdvaMed Member Registration (< $30 Million gross sales): $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,295.00

Please contact for Group Discounts.