AdvaMed PMA Submissions Workshop

February 27 - February 28, 2020

PMA Submissions Workshop - Spring 2020
February 27, 2020 to February 28, 2020
Irvine, CA

Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.

Agenda topics include:

  • Steps to develop a PMA submission strategy
  • Best practices of quality system information for PMA applications
  • What to expect during a submission review
  • Preparation needed for an advisory panel meeting
  • Tips to prepare for an inspection
  • Ins and outs of BIMO inspections
  • How to deal with unexpected clinical outcomes, animal test results, and adverse panel recommendations
  • Needed supplemental submissions for approved PMAs
  • Real world case studies
  • And more!

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