Agenda At-A-Glance

Wednesday, July 20, 2016

1:00 – 5:00
(Registration begins at 12:30)
Pre-Conference Primer: Fundamentals of FDA Regulatory Device Law

Day One, Thursday, July 21, 2016

7:00 Registration & Continental Breakfast 7:45 Co-Chairs’ Opening Remarks 8:00 Overview of Device Regulation 8:45 Understanding FDA Enforcement Tools, Policies, Practices, and Trends 9:45 Morning Coffee Break

Pathways to Approval

10:00 FDA Keynote: Postmarket Benefit: Risk, A Proposed Approach to Making Compliance and Enforcement Decisions for Medical Devices 10:30 Low to Moderate-Risk Devices – Clarification of the 510(k) Clearance and Dissecting the De Novo Classification 11:30 High-Risk Devices – Parsing the Premarket Approval Process (PMA) 12:30 Networking Luncheon

Ripped from the Headlines: Breaking News, Hot Cases, and Emerging Trends that Impact FDA Practice

1:30 The First Amendment and Off-Label Enforcement: Understanding the Impact of the Caronia/Amarin/Pacira/Vascular Solutions Cases on the Medical Device and FDA-Related Industries 2:30 Digital Health 3:45 Afternoon Refreshment Break 4:00 Refurbishment and Reusable Devices 4:45 Unique Device Identification (UDI) 5:45 Conference Adjourns to Day Two

Day Two, Friday, July 22, 2016

7:45 Continental Breakfast 8:35 Co-Chairs’ Opening Remarks and Recap of Day One

Complying with General Post-Market Controls

8:45 Quality System Regulation 9:45 Medical Device Reporting 10:45 Morning Coffee Break 11:00 Recalls and Withdrawals 12:00 Labeling and Promotion 1:00 Conference Concludes
Lunch for Master Class Participants

Friday, July 22, 2016

2:00 – 5:00 Post-Conference Master Class: Deep Dive into the Unique Regulatory Schemes for Specialized Devices: IVDs, LDTs, Companion Diagnostics, and Combination Products