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.
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!
Courtyard Irvine Spectrum | 7955 Irvine Center Drive | Irvine, CA 92618
Speakers will include:
- Andrew Van Haute, Sidley Austin
- Yarmela Pavlovic, Hogan Lovells
- Frank Pokrop, Sotera Wireless, Inc
- Quynh Hoang, King & Spalding
- Respresentatives from FDA
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00