This session will provide a practical framework for working effectively with FDA throughout the medical device review process, recognizing that neither “naive harmony” nor inevitable conflict is a realistic approach to FDA interactions. Whether engaging with FDA through a Pre-Submission meeting or navigating the review of a 510(k), De Novo, or PMA, effective communication, strategic preparation, and an understanding of how FDA works can make a significant difference in the outcome.
Participants will learn how FDA review groups operate, how different reviewers and levels of management may influence the review process, and how seemingly minor miscommunications can develop into significant regulatory disagreements. The session will explore practical strategies for communicating with FDA, asking questions that elicit useful feedback, and using Pre-Submission meetings effectively to identify and address regulatory issues before they become submission-stage problems.
A particular focus will be placed on meeting minutes and the importance of creating an accurate record of FDA interactions. Participants will learn how to strategically frame Pre-Submission questions, how to distinguish between FDA feedback and actual agreements, and how to appropriately document FDA's recommendations and the sponsor's understanding of those discussions. The session will also address what to do when FDA's subsequent actions appear inconsistent with previous discussions or agreements.
Most importantly, participants will learn to recognize the warning signs that an FDA interaction or review may be heading in an unproductive direction. Rather than either immediately escalating a disagreement or simply accepting every FDA request, participants will learn how to assess the situation, determine the appropriate response, and work toward resolution at the lowest appropriate level.
Finally, the session will address when and how to challenge FDA and when escalation within the Agency may be appropriate. Participants will learn strategies for respectfully challenging regulatory positions, preparing a persuasive rationale, identifying when additional management involvement is warranted, and escalating concerns without unnecessarily damaging the working relationship with the review team.
The goal is not to teach participants how to “win” an argument with FDA. It is to help them develop the judgment and communication skills needed to work productively with FDA, manage disagreement when it occurs, prevent avoidable escalation, and recognize when escalation is necessary to keep a device development or review program moving forward.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Mark DuVal JD, FRAPS
Allison Komiyama, PhD, RAC, FRAPS
