Survivor: The FDA 510(k) Program Edition (Day 1 of 2)

Preconference Workshop Description: In the popular television series Survivor, individuals are placed on an island isolated from reality with odds stacked against them, trying to fight for their survival while the rulers of the island are constantly changing the rules, making it difficult to survive. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island with little chance to be a survivor. Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to becoming the survivor. Unlike Survivor – there is plenty of room for more than one to survive the 510(k) program.
The majority of medical devices come to the US market through the 510(k) program. Although the regulatory criteria have not changed, FDA has significantly reshaped (expanded) its expectations over the years, leading to ever-increasing complexity in 510(k) submissions. This makes it much more difficult to obtain a positive clearance decision, particularly for today’s innovative products.
In this two-day, pre-conference workshop, regulatory experts will review the current requirements and expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program, providing you with the tools to be a survivor of this ever-changing program.

Proposed Preconference Workshop Agenda Outline:

Day 1:

7:30 -8:30 AM Breakfast & Morning Welcome by RAPS

8:30 – 8:40 AM: Introduction

8:40 – 9:15 AM: History of the 510(k)

9:15 – 10:30 AM: 510(k) Structure, Timing, and Guidance

10:30 – 11:00 AM Networking Break by RAPS

11:00 AM – 12:30 PM: Definitional Elements

12:30 – 1:30 PM: Networking Lunch Break by RAPS

1:30 – 2:00 PM: Regulatory Strategy

2:00 – 3:00 PM: 510(k) Sections Part 1

3:00 – 3:15 PM: Networking Break by RAPS

3:15 – 4:00 PM: 510(k) Sections Part 2

4:00 PM: Adjournment of All Preconference Workshops by RAPS

 

Day 2:

7:30 -8:30 AM Breakfast & Morning Welcome by RAPS

8:30 – 9:30 AM: Administrative Aspects

9:30 – 10:00 AM: Use of Q-Sub Interactions

10:00 – 10:30 AM: FDA Interaction Points and Interpretation

10:30 – 11:00 AM Networking Break by RAPS

11:00 – 11:45 AM: Post-Clearance Activities

11:45 AM – 12:30 PM: Getting Review Process Back on Track

12:30 – 1:30 PM: Networking Lunch Break by RAPS

1:30 – 2:00 PM: Role of the Ombudsman

2:00 – 3:00 PM: Best Practices for managing communications with FDA

3:00 – 3:15 PM: Networking Break by RAPS

3:15 – 4:00 PM: Survivors Panel: Learning from Real World 510(k) Survivor Stories
4:00 PM: Adjournment of All Preconference Workshops by RAPS