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PMA Submissions Workshop

October 19, 2017 to October 20, 2017
Washington, DC

Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.

510(k) Submissions Workshop October 16-17 | Washington, DC - Learn more here
IDE Submissions Workshop October 18 | Washington, DC - Learn more here

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Click here to view and download the agenda

Agenda topics include:

  • Steps to develop a PMA submission strategy
  • Best practices of quality system information for PMA applications
  • What to expect during a submission review
  • Preparation needed for an advisory panel meeting
  • Tips to prepare for an inspection
  • Ins and outs of BIMO inspections
  • How to deal with unexpected clinical outcomes, animal test results, and adverse panel recommendations
  • Needed supplemental submissions for approved PMAs
  • Real world case studies
  • And more

Speakers include:

  • Bleta Vuniqi, CDRH/Office of Compliance, FDA
  • Melissa Sage, CDRH/Office of the Center Director, Ombudsman Office
  • Abiy Desta, CDRH/Office of the Center Director, Ombudsman Office
  • David Armor, Founder Partner Qara Partners and Strategic Partner, MasterControl Inc.
  • Irfan Khan, CDRH Office of Compliance, Division of Bioresearch Monitoring, FDA
  • Gerard Prud’homme, Hogan Lovells
  • Susan Resnick, 3D Communications
  • Janice Hogan, Hogan Lovells
  • Mark Fellman, Biomedical Engineer, CDRH, FDA
  • Quynh Hoang, King & Spaulding
  • April Marrone, CDRH/Office of Device Evaluation (ODE), FDA
  • Additional speakers to be announced

Grand Hyatt Washington
1000 H Street NW
Washington, DC 20001


Grand Hyatt Washington
1000 H Street NW
Washington, DC 20001

Room rate: $315.00
Cutoff date for reservations: September 22, 2017
Click here to reserve your room

AdvaMed Member Registration: $1,595.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $2,095.00

Cancellation and Refund Policy

All cancellations must be received via email to 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 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.