Sponsorships and Speaking Engagements | 14 May 2019 | Irvine, California, United States

510(k) Submissions Workshop - Spring 2019

Yarmela Pavlovic was a speaker at the 510(k) Submissions Workshop – Spring 2019. This opportunity helped attendees better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. The workshop covered actionable insights and strategies for assembling and streamlining an effective 510(k) submission.

Agenda topics included:

  • 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 the FDA during the 510(k) review process.
  • Deciding when to submit a new 510(k) for a device modification.



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