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  • 1.  FDA Informational Meetings

    Posted 16-Jun-2022 19:51
    Hello!

    I'm interested in others' experience with informational meetings with FDA. I have a lot of experience with PreSubs, but I have never requested an informational meeting before. When is this an appropriate avenue? Any insights or lessons learned, apart from what's written in the guidance (below)? 

    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.

    I am working with on a QSub in preparation for a 510(k), and the company would like to demonstrate or show the device to FDA. We are going to include an animation video. With no face-to-face meetings, would you also consider sending the lead reviewer a sample/prototype? This is not a high risk device, and the technology is interesting, so I think a sample would really help with understanding. What are the downsides?


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    Marianne Jacklyn
    Principal Consultant
    West Linn OR
    United States
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  • 2.  RE: FDA Informational Meetings

    This message was posted by a user wishing to remain anonymous
    Posted 17-Jun-2022 12:20
    This message was posted by a user wishing to remain anonymous

    These can be very helpful, depending on your relationship with the agency. In past life, we would bring the CEO, head of RA, and a key R&D representative, and we'd go over our portfolio for the next year or more. We'd talk about our proposed regulatory pathway and testing but only at a high level (e.g., Real-time review, 180-day) and we'd highlight novel technology or new approaches we were considering. FDA would respond about red flags to consider regarding our approaches. 

    I think what your company wants to do fits into this well. The video is great. The prototype may depend on how novel/creative you are getting. Reviewers do like to see the products, but some regulatory folks will object to letting them look at it so closely and get distracted with potentially less relevant aspects, like looking at the material strength if your focus was meant to be something else. Another option is to hold the meeting as planned with the video and then bring the real product to one of FDA's demo days like they used to have for pediatric products. I imagine those might be on hold still but wouldn't be surprised if they resumed.
    Original Message


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