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IDE Submissions Workshop - Fall 2018

October 17, 2018
Washington, DC
Regulatory
Workshop

Join us in Washington, D.C. where FDA and industry experts will come together to lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. This unique opportunity will help you better understand the FDA perspective on IDE submissions, from processes to approval to modifications. Throughout the 1-day workshop, you’ll obtain actionable insights and strategies for assembling and streamlining an effective IDE submission.

Click here to learn more about the 510(k) Submissions Workshop

Click here to learn more about the PMA Submissions Workshop

Take advantage of our group discounts
3 or more attendees - save 15% (use code group15 at checkout)
5 or more attendees - save 20% (use code group20 at checkout)


This course has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.

Click here to view and download the agenda

Agenda topics will include:

  • The purpose of an IDE
  • Tips on making the best use of pre-submission meetings
  • Components of a successful IDE submission
  • Common errors and deficiencies in an IDE application
  • The ins and outs of BIMO inspections
  • Details about the regulatory requirements needed during trial conduct
  • And more

Grand Hyatt Washington
1000 H Street NW
Washington, DC 20001

Hotel Reservations:
Room rate:  $325
Room cut-off date:  Sept. 21, 2018
Reservation link: https://book.passkey.com/event/49486011/owner/544/home

AdvaMed Member Registration: $995.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $1,295.00

Cancellation and Refund Policy

All cancellations must be received via email to AdvaMedEvents@AdvaMed.org. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows". 

We welcome substitutions in lieu of cancellations at any time. Please contact us at AdvaMedEvents@AdvaMed.org with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.

Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.