Contents of a Pre-Submission for FDA Feedback

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning.
There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share recommendations about what content to include in a Pre-sub request to FDA as well as costly pitfalls to avoid with this particular Q-submission type.
Get additional episode details by visiting www.greenlight.guru/blog/prep...