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I'm sure this can differ depending on your OHT, but I'm a big fan of these. It's good to understand FDA's perspective, and it gives them an opportunity to understand your device and roadmap better so when they receive your written PMA it makes more sense.
1. You don't need to provide a specific timeline, but it can be helpful to give rough estimates so FDA understands the order of the submissions you intend. They know timing changes.
2. Take detailed minutes to save internally, almost like a script. For the minutes you send to FDA, remove FDA speaker names. In other words, don't write, "Chris said..." Instead, summarize in organized sections what you think the company committed to and what FDA agreed to or suggested in response. Know that they will provide redlined minutes back if they disagree with your statements. If there is one take-away that is really important for your company, capture that in the minutes multiple times with different wording to ensure that any future FDA redlines are just due to wording and not contradicting the take-away.
3. Definitely worth the time if you are organized, clear, and willing to consider FDA's feedback. If your company is going to ignore what FDA said, don't bother with the meeting. I can't imagine anything more frustrating that someone ignoring advice given by a very busy agency. That doesn't mean you have to follow everything 100% to the letter, but if you go against their suggestions, you should very clearly explain why to them so they don't think they just wasted their time on you.
Original Message:
Sent: 13-Dec-2022 14:10
From: Anonymous Member
Subject: Informational Meeting - looking for any lessons learned?
This message was posted by a user wishing to remain anonymous
Hello everyone, our team is planning to go for an informational meeting with FDA for a class 3 product. I have a couple of questions and also looking for some folks to share their experiences.
- Do we need to provide specific timelines on our path forward? What if we cannot meet those timelines?
- How can we use meeting minutes from informational meeting to our best advantage?
- Is going into informational meeting really worth the time? Pros and cons?
Thank you