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What is an Informational Meeting?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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.

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