Pre-Submission Roleplay with FDA

You have precisely 60 minutes to show FDA what you have and learn if they feel your evidence will be sufficient for a successful 510(k) submission.

It’s not a chat session. It’s not “building relationships and getting early buy-in.” And you don’t want to ask questions to which you already know the answer or – worse – to which you really don’t want to know the answer.

Larry Stevens, formerly FDA, will roleplay his reaction to the questions Rob Packard and Michelle Lott in this simulated pre-submission meeting.

Fun and educational!