Module 15 Presentations

15/04/2024

What is involved with an IDE submission?

The Organisation for Professionals in Regulatory Affairs

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Q-Submission Meeting Requests Q-Submission meeting request is an opportunity to interact with FDA and get their feedback on test plans – both nonclinical and clinical

Q-Submissions can be used for multiple pathways • Device classification or designation • IDE clinical trial for significant risk device • Pre-Submission for reviewing market application approach

Can be used to lower risks with IDE clinical studies and other clinical studies to reach clearance/approval faster Clinical synopsis can be submitted to discuss high level plans or clinical protocol can be submitted to discuss the proposed study in more detail

The Organisation for Professionals in Regulatory Affairs

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