Regulatory Open Forum

I recently met with a consultant regarding a new product we are working on and the regulatory pathway. In that meeting, it was mentioned that an 'informational meeting' would be beneficial to introduce the FDA to what we are trying to accomplish, what our proposed study endpoints would be, and just introduce them to our product.

For those of you who have done an informational meeting before...

1. What is the best time to do this meeting?
   
   Should it be six months in advance to a pre-submission meeting, directly before the meeting, timing doesn't matter? If we do an informational meeting and then a year later do a pre-sub, would that informational meeting be a waste (as so much time has passed)? What's the time-value here?
   
   
2. What is the typical format and content of an informational meeting?
   
   Within the guidance, Requests for Feedback and Meetings for Medical Device Submissions:The Q-Submission Program (here) I found the following explanation:
   

"An Informational Meeting is a request to share information with FDA without the expectation of feedback. This information sharing can be helpful in providing an overview of ongoing device development (particularly when there are multiple submissions planned within the next 6-12 months) and familiarizing the FDA review team about new device(s) with significant differences in technology from currently available devices. While FDA staff may ask clarifying questions during an informational meeting, they will generally be listening during the meeting and not prepared to provide any feedback. Informational Meetings can also be used to document FDA and submitter interactions that do not fall within the definition of the other types of Q-Submissions. Additional information on these can be found in Section III.F of this document."

Thank you for your insight!

I do like having these meetings. Ideally, they happen 6-9 months before a pre-sub and/or IDE. They are a good chance for you to explain your product, your target patients and outline your development plans. They are also a good way to get prototypes in the hands of the FDA team (so they can better conceptualize in the future). Most importantly, it lets you know who the review team will likely be and start to establish to them that you are legitimately experts in the space and intend to do things correctly and not just try to do the bare minimum or worst yet do something sneaky. 

Yes, they generally won't give binding advice in these meetings. However, you can learn a lot about their pre-conceived notions by the questions they ask, which will help you plan and position things in future meetings and submissions. More importantly, they will have had several months to consider things before your Qsub comes in, so my experience is you get much better feedback at that time, because you have already sorted out any misunderstandings about what the device is and how it works

g-

I recently met with a consultant regarding a new product we are working on and the regulatory pathway. In that meeting, it was mentioned that an 'informational meeting' would be beneficial to introduce the FDA to what we are trying to accomplish, what our proposed study endpoints would be, and just introduce them to our product.

For those of you who have done an informational meeting before...

1. What is the best time to do this meeting?
   
   Should it be six months in advance to a pre-submission meeting, directly before the meeting, timing doesn't matter? If we do an informational meeting and then a year later do a pre-sub, would that informational meeting be a waste (as so much time has passed)? What's the time-value here?
   
   
2. What is the typical format and content of an informational meeting?
   
   Within the guidance, Requests for Feedback and Meetings for Medical Device Submissions:The Q-Submission Program (here) I found the following explanation:
   

"An Informational Meeting is a request to share information with FDA without the expectation of feedback. This information sharing can be helpful in providing an overview of ongoing device development (particularly when there are multiple submissions planned within the next 6-12 months) and familiarizing the FDA review team about new device(s) with significant differences in technology from currently available devices. While FDA staff may ask clarifying questions during an informational meeting, they will generally be listening during the meeting and not prepared to provide any feedback. Informational Meetings can also be used to document FDA and submitter interactions that do not fall within the definition of the other types of Q-Submissions. Additional information on these can be found in Section III.F of this document."

Thank you for your insight!