Agenda At-A-Glance

PRE-CONFERENCE WORKSHOP

Wednesday, July 20, 2016

1:00 – 5:00
(Registration begins at 12:30)

Pre-Conference Primer: Fundamentals of FDA Regulatory Device Law

MAIN CONFERENCE

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

MAIN CONFERENCE

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

POST-CONFERENCE WORKSHOP

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