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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.Some highlights of this episode include:A Pre-submission meeting is an opportunity to communicate with FDA prior to a marketing submission.About 3,306 medical device-related Pre-submission requests were made to FDA in 2020. In 2021, more than 1,500 Pre-submission requests have been made so far.Not all Pre-submission requests are made for meetings with FDA. About two-thirds of