Conference Agenda

We are still optimizing the agenda and will continue to update this page as the travel arrangements for our speakers becomes finalized. Sessions will include formal speaker presentations, case studies, panel discussions, and break-out sessions. Breaks include coffee/light snacks and lunch will be provided all three days (breakfast and dinner are not provided). Please join us for a reception event with drinks and hors d’oeuvres on the first night.

 
 
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Day 1 - Monday, August 19

7:00-8:00am — Check-In (No day-of registration)
8:00-8:30am — Welcome and kick-off address
8:30-10:00am — FDA Device Classification
10:00-10:15am — BREAK
10:15-11:45am — Regulatory Strategy for your Medical Device
12:00-1:30pm — LUNCH
1:30-3:00pm — Pre-submission Boot-Camp (Part 1 of 2)
3:00-3:15pm — BREAK
3:15-4:45pm — Pre-submission Boot-Camp (Part 2 of 2)
5:15-6:30pm — Social Event
On your own for dinner! Need a recommendation? Click HERE

 
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Day 2 - Tuesday, August 20

8:00-8:30am — Recap of Day #1, Reg Chats
8:30-10:00am — Premarket Submissions 510(k)s (Part 1 of 4)
10 -10:15am — BREAK
10:15-11:45am — Combination Products and CBER devices
12:00-1:30pm — LUNCH
1:30-3:00pm — Premarket Submissions de novos (Part 2 of 4)
3:00-3:15pm — BREAK
3:15-4:45pm — Digital Health and Cybersecurity
On your own for dinner! Need a recommendation? Click HERE

 
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Day 3 - Wednesday, August 21

8:00-8:30am — Recap of Day #2, Reg Chats
8:30-10am — Premarket Submissions IDEs/HDEs (Part 3 of 4)
10:00-10:15am — BREAK
10:15-11:45am — Real World Evidence & Patient Preference
12:00-1:30pm — LUNCH
1:30-3:00pm — Premarket Submissions PMAs (Part 4 of 4)
3:00-3:15pm — BREAK
3:15-4:45pm — FDA & EU MDD/MDR Comparison
4:45-5:00pm — Final Thoughts and Farewell!