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!
The 510(k) Submissions Workshop will take place November 24-25 at the Courtyard Irvine Spectrum in Irvine, CA.
Room Rate: $174.00
Reservation Cutoff Date: Monday, February 3, 2020
7955 Irvine Center Drive
Irvine, CA 92618
AdvaMed Member Registration: $1395.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,895.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by January 25, 2019 for $200 off your registration!