510(k) Submissions Workshop - Spring 2021

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.