510(k) Submissions Workshop

February 25 – 26, 2013 — Sheraton Crystal City, Arlington, VA

Overview |  Agenda |  Speakers |  Logistics |  Fees


Join quality and regulatory professionals at this interactive 510(k) workshop. Industry experts and key personnel from the FDA CDRH and CBER 510(k) staff inform you in detail on:

  • - Current FDA’s updates to the 510(k) process (Refuse to Accept Policy for 510(k)s)
  • - A step-by-step walkthrough of the 510(k) regulatory guidelines
  • - 510(k) practical steps & strategic considerations for determining a product's regulatory route to market
  • - Identifying a predicate device
  • - Planning and assembling a 510(k) submission
  • - Interacting with FDA during the 510(k) review process
  • - 510(k) post-clearance issues
  • - eCopy Program for Medical Device Submissions

Sponsored by:

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


"Overall extremely helpful, well-organized. Appreciated hearing directly from the FDA staff about upcoming changes to the review process."

“I had no prior experience with 510(k) submissions. The MTLI course enabled me to learn the mechanics of such type of submissions in a small and informal setting. It was easy to talk to the instructors and the other experts from the related fields.”

"The speakers and information presented were excellent. I attended a 3 day conference on various FDA topics 2 weeks ago that was less than average compared to this event."

"I enjoyed the quizzes and interactive exercises. It was a great way to try and apply some of what we learned. Overall, it was a good experience and I look forward to being able to attend other MTLI courses in person or online."

"I am very new to regulatory affairs, having transferred from the quality system world. This seminar was really informative and helped gain a better understanding of the 510(k) process."

This workshop is pre-approved by RAPS as eligible for up to 12 credits towards a participants RAC re-certification upon full completion.


Click here to Download.


Author of Refuse to Accept Policy for 510(k)s:
Geeta Pamidimukkala, Biomedical Engineer, FDA/CDRH

Lawrence "Jake" Romanell, Deputy Ombudsman, FDA/CDRH, Office of the Center Director
Marjorie Shulman, Director, Premarket Notification Program, ODE/CDRH/FDA
Tony Blank, Cofounder & Senior Advisor, Barton & Blank, LLC
Sheri Hall, Vice President, Regulatory Affairs, BD
Phil Phillips, President, Phillips Consulting Group, LLC
Michael Santalucia, Vice President, Regulatory, Terumo Cardiovascular Systems
David West, Vice President, Medical Device Development, Quintiles Consulting

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: $1,595.00
AdvaMed Member Registration (< $30 Million gross sales): $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00

Please contact ssmith@advamed.org for Group Discounts.