The FDA requirements for submission of a medical device in the US have many facets to navigate. The process can be complex, requiring an understanding of the De Novo Request Application process of the Food and Drug Administration (FDA).
In this third video of a five-part video series on Marketing your medical device in the US, we would like to take you through the De Novo Application that can be submitted in response to the Not Substantially Equivalent (NSE), issued against an 510(K) application or based on the outcome of Q-Submission Meeting.
The goal is to give you a go-to guide, that is easy to follow, can lead you in the right direction, and will ultimately prepare you for a successful product launch. Let’s get started with a visual overview of De Novo Request Application process.
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