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510(K) Submissions Workshop - Spring 2019

May 13, 2019 to May 14, 2019
Irvine, CA
Regulatory
Workshop

Register now and save $200 with early bird pricing!

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.

Click here for the agenda

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!

Hotel Information
Courtyard Irvine Spectrum | 7955 Irvine Center Drive | Irvine, CA  92618
Room rate:  $189.00
Cut-off Date for reservations:  Monday, April 22, 2019.
Reservations Link: Book your group rate for Advamed Submissions Workshop