510(k) Submissions Workshop

February 22 – 23, 2016 — Irvine Marriott, Irvine, CA

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

FDA (invited) and industry experts are coming together to teach you the basics of 510(k) submissions.

Agenda Topics Include:

  • FDA’s updates to the 510(k) process
  • Different types of 510(k)s
  • Considerations for determining a product's regulatory route to market
  • Factors to consider when planning and assembling a 510(k) submission
  • Tips and hints on interacting with FDA during the 510(k) review process
  • Deciding when to submit a new 510(k) for a device modification
  • And more

Presentation slides will be sent after the conclusion of the workshop. 

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

Agenda

Click here to Download.

Speakers

Speakers include the following:

  • Sonali Gunawardhana, Counsel, Wiley Rein LLP
  • Marilyn Waxberg, Senior Principal Advisor, Regulatory and Quality Solutions (R&Q)
  • Nancy Morrison, Director of Regulatory Affairs, Regulatory and Quality Solutions (R&Q)
  • Frank Pokrop, Director, Quality and Regulatory Affairs, BD
  • Greg Payne, Director, BD
  • Marjorie Shulman, Director, Premarket Notification Program, ODE/CDRH/FDA
  • Mike Bailey, FDA
  • Pamela Forrest, Partner, King & Spalding, LLP

Hotel & Meeting Logistics

Irvine Marriott
18000 Von Karman Avenue
Irvine, CA 92612
949-553-0100

Reserve your room here or contact Marriott Reservations Desk directly at 1-800-228-9290. Specify the Advanced Medical Technology Association

Cut-off date for reservations is Friday, February 12, 2016.
Room rate is: $189.00 single/double
 

Can't make this date? We are offering the same workshop this fall.  Click here to learn more.

Registration Fees

AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00


Please contact skinchen@advamed.org for Group Discounts.