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. Click here to register.
Agenda topics include:
FDA guidance for 510(k):
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! Click here to view the tentative agenda.
AdvaMed Member Registration: $1195.00
Accel Member Registration: $550.00
Government and Non-Profit Registration: $550.00
Non-Member Registration: $1,595.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members until February 12, 2021. Register now for $100 off your registration!