Module 15 2022

19/05/2022

What is involved with an IDE submission?

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Pre-Submissions

Pre-Submissions are opportunities to interact with FDA and get their feedback on test plans.

Can be used to de-risk the IDE and reach approval faster.

Test plans can be high level or more detailed. A clinical synopsis can be submitted to discuss high level plans or clinical protocol can be submitted to discuss the proposed study in more detail.

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