FDA and industry experts are coming together to review 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:
- Guidance for 510(k): general & product specific
- 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 (staff involved, RA responsibilities, etc)
- 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!
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by September 13, 2019 for $200 off your registration! Also, check your confirmation email for opportunities to save even more on your next workshop!