510(k) Submissions Workshop
February 22 – 23, 2016 — Irvine Marriott, Irvine, CA
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.
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
18000 Von Karman Avenue
Irvine, CA 92612
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.
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