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
8:30-9:15am — Background of Regulations and FDA Oversight
9:15-10:00am — FDA Device Classification and Comparison to EU Classification
10:00-10:15am — BREAK
10:15-11:00am — Case Studies: Classifying your Medical Device
11:00-11:30am — Case Studies: Defining a Test Plan for your Medical Device
11:30-11:45am — Ask Me Anything: How Poor Classification can Impact your Timeline to Market
11:45am-12:00pm BREAK
12:00-1:30pm — NETWORKING LUNCH
1:30-3:00pm — Pre-submission Boot-Camp: Different Types of Pre-Subs and Figuring out Which is Right for you
3:00-3:15pm — BREAK
3:15-3:45pm — Pre-submission Boot-Camp: What Comes Next and How to Submit a 513(g) or Pre-Sub Supplement
3:45-4:30pm — Pre-Submission Boot-Camp: Speaker Panel on Best Practices for Pre-Sub Meetings
4:30-4:45pm — Wrap up of Day 1
5:00-6:30pm — Social Event


On your own for dinner! Need a recommendation? Click HERE

 
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Day 2 - Tuesday, August 20

7:45-8:00am — Check-In
8:00-8:15am — Recap of Day #1, Reg Chats
8:15-9:30am — 510(k)s: How to Write and Submit a Successful 510(k)
9:30-10:00am — 510(k)s: “To LTF or not to LTF…” When to Submit a 510(k) for a Change to an Existing Device
10:00-10:15am — BREAK
10:15-10:45am — Combination Products: How to Prepare a Request for Designation
10:45-11:45am — Point of Care IVD Submissions and the Routes to CLIA Waiver
11:45am-12:00pm — BREAK
12:00-1:30pm — NETWORKING LUNCH
1:30-2:00pm — Ask Me Anything: 510(k), LTF, RFD, and IVD Horror Stories
2:00-3:00pm — De novos: How to Prepare your de novo Application
3:00-3:15pm — BREAK
3:15-4:00pm — Hot Topic: Digital Health (Software as a Medical Device, Cybersecurity, and Artificial Intelligence)
4:00-4:30pm — Hot Topic: Digital Health Panel
4:30-4:45pm — Wrap up of Day 2


On your own for dinner! Need a recommendation? Click HERE

 
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Day 3 - Wednesday, August 21

7:45-8:00am — Check-In
8:00-8:15am — Recap of Day #2, Reg Chats
8:15-9:15am — IDEs: How to Prepare a Successful IDE and What to do Post-Approval
9:15-10:00am — HDEs: How to Prepare a Successful HDE and How to use the Pathway to Expand your Future Indications
10:00-10:15am — BREAK
10:15-11:00am — Hot Topic: Clinical Evidence (Using Real World Evidence, Expanding to Pediatric Indications, Evaluating Patient/Rx Preference)
11:00-11:45am — Hot Topic: Clinical Evidence Panel
11:45am-12:00pm — BREAK
12:00-1:30pm — NETWORKING LUNCH
1:30-2:30pm — PMAs: How to Prepare a successful PMA and have Effective Meetings with FDA
2:30-3:00pm — PMAs: What to do Post-Approval and How to Submit a Supplement
3:00-3:15pm — BREAK
3:15-3:45pm — FDA & EU MDD/MDR Comparison: A New Landscape for CE Marking
3:45-4:30pm — Developing your Technical File or Design Dossier
4:30-4:45pm — Wrap up of Day 3 & Farewell!