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Episode 26  |  30:38 min

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Episode 26  |  30:38 min  |  11.07.2019

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

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This is a podcast episode titled, How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues. The summary for this episode is: In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within the submission itself. The indications for use statement is not the same as within the submission itself. “There is no bigger fan of communication with the FDA. But, there is a caveat to that. That is, tell don’t ask, lead don’t follow.” - Mike Drues Today’s guest, is Mike Drues from Vascular Sciences. Mike is a professional in medical device industry for 25 years will talk about the importance of the pre-submission of medical devices to the FDA. “We need to be able to go to the FDA with a well thought out development plan.” - Mike Drues Jon and Mike have a great discussion on how to use pre-submission to bring product to market. Here are some of the specific topics you’ll hear discussed today: What is a pre-submission and why is it important. - The power of pre-submission process and going beyond the guidelines. Common reasons why the FDA rejects a submission. - How to properly communicate with the FDA. - How early should you go to talk to the FDA about your medical device. - How to prepare for a pre-submission meeting with the FDA. - What are some other ways that a pre-submission can be useful for companies. If you found today's episode valuable, and need advice on pre-submission, Mike encourages you to get in touch with him. He is a great resource and is happy to give advice on how to use pre-submissions to get your medical device to market.