AdvaMed: PMA Submissions


Completing the MTLI set of interactive submissions workshops, Senior Industry Experts and members of the CDRH device evaluation and bioresearch monitoring staff (invited) will lead professionals through the strategic considerations and practical steps of filing a Premarket Approval. Topics to be discussed 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