FDA and industry experts are coming together to teach you the basics of 510(k) submissions.
This unique opportunity will help you better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the 2-day workshop, you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission.
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 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
- Angela DeMarco, Biomedical Engineer, ODE/CDRH, FDA
- Linda Chatwin, Esq, RAC, Senior Customer Solutions Consultant, Emergo, a UL Company; Strategic Partner MasterControl Inc.
- Marjorie Shulman, Director, Premarket Notification Program, ODE/CDRH, FDA
- Tony Blank, Cofounder & Senior Advisor, Barton & Blank LLC
- Kelliann Payne, Counsel, FDA Medical Devices Regulatory Practice Group, Hogan Lovells LLP
- Additional speakers to be announced
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 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.