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Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
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Repeat Solutions Circle
Evaluation ViewAttendees 10

Devices (includes Medical Devices & In Vitro Diagnostics)

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

Tuesday, October 7, 2025
8:30 AM - 4:00 PM EST
Location/Room: 315
Preconference Workshop Description: In the popular television series Survivor, individuals are placed on an island isolated from civilization with odds stacked against them. They fight for their survival while the rulers of the island are constantly changing the rules, making it difficult to survive.
The majority of medical devices come to the US market through the US Food and Drug Administration (FDA)’s 510(k) program. Although the regulatory criteria have not changed, FDA has significantly expanded its expectations over the years, leading to ever-increasing complexity and uncertainty in 510(k) submissions.

These changes make it more difficult to obtain a clearance decision from the agency, particularly for today’s innovative products.

Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to suffer an early exit from FDA island with little chance to survive.

Gaining an understanding of the 510(k) program and its evolving expectations is like being equipped with minimalistic clothes, shelter, tools, and food and told to survive. Unlike Survivor – there is plenty of room for more than one survivor in the 510(k) program, but it takes planning and resilience.

Preconference Workshop Agenda Outline:

Day 1:

  • 7:30 - 8:30 am: Breakfast for Preconference Workshop Attendees

  • 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: Refreshment Break for Pre-conference Workshop Attendees

  • 11:00 AM - 12:30 PM: Definitional Elements

  • 12:30 - 1:30 PM: Lunch for Pre-Conference Workshop Attendees

  • 1:30 - 2:00 PM: Regulatory Strategy

  • 2:00 - 3:00 PM: 510(k) Sections Part 1:Executive Summary, Forms, Device Description, Substantial Equivalence

  • 3:00 - 3:15 PM: Break for Pre-Conference Workshop Attendees

  • 3:15 - 4:00 PM: 510(k) Sections Part 2: Performance testing, labelling, software, cybersecurity, EMS/ES, PCCP

  • 4:00 PM: All Preconference Workshops Adjourn for Day


Day 2:

  • 7:30 - 8:30 am: Breakfast for Preconference Workshop Attendees

  • 8:30 - 9:30 AM: Administrative Aspects of Submission

  • 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: Refreshment Break for Pre-conference Workshop Attendees

  • 11:00 AM - 12:00 PM: Post-Clearance Activities

  • 12:00 - 12:30 PM: Getting the Review Process Back on Track

  • 12:30 - 1:30 PM: Lunch for Pre-Conference Workshop Attendees

  • 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: Break for Pre-Conference Workshop Attendees

  • 3:15 - 4:00 PM: 510(k) Survivors Panel: Learning from Real World 510(k) Survivor Stories

  • 4:00 PM: All Preconference Workshops Adjourn for Day

Learning Objectives:

  • Explain how to select an appropriate predicate device.
  • Prepare a 510(k) submission that appropriately advocates for its clearance.
  • Demonstrate how to use available tools to get a submission review process back on track and challenge the Agency when things do not go as planned.