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Episode 216  |  36:29 min  |  06.23.2021

Preparing Your Pre-Submission with the Content FDA Wants to See

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This is a podcast episode titled, Preparing Your Pre-Submission with the Content FDA Wants to See. The summary for this episode is: <p><span style="background-color: transparent; color: rgb(0, 0, 0);">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.</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">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 </span><span style="color: rgb(0, 0, 0);">recommendations about what content to include in a Pre-sub request to FDA </span><span style="color: rgb(0, 0, 0); background-color: transparent;">as well as costly pitfalls to avoid with this particular Q-submission type.</span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">A Pre-submission meeting is an opportunity to communicate with FDA prior to a marketing submission.</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">Not all Pre-submission requests are made for meetings with FDA. About two-thirds of Pre-subs requested a meeting and one-third requested written email communication only.</span></li><li><span style="background-color: transparent;">On average, FDA takes two months to give a written response of approval or denial for a Pre-submission request.</span></li><li><span style="background-color: transparent;">A Pre-submission is completely optional and never required, but highly recommended.</span></li><li><span style="background-color: transparent;">The only time that Mike does not recommend a Pre-sub is when the marketing submission is a ‘slam dunk’ in terms of the agency's decision. That rarely seems to occur, especially because 75% of 510(k)s and 89% of PMAs are rejected the first time.</span></li><li><span style="background-color: transparent;">Unlike 510(k) and PMA submissions, as well as 513(g) requests for information, there is no user fee associated with Pre-submissions.</span></li><li><span style="color: rgb(0, 0, 0);">When crafting a Pre-submission, justify reasons for why certain approaches are being taken over others.</span></li></ul><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Memorable Quotes from Mike Drues:</strong></h3><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“A Pre-submission meeting is an opportunity to talk to the FDA before you actually make your submission.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Clearly, the popularity of the program is increasing.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“A Pre-sub is purely optional. It is never required. A company can choose to do a Pre-sub or not.”&nbsp;</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Unlike 510(k) and PMA submissions, unlike 513(g) requests, and so on, there is no user fee associated with the Pre-sub—although at least not yet.”</em></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Links:</strong></h3><p><a href="https://www.fda.gov/media/114034/download" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Q-Submission Guidance - </a><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program</a></p><p><a href="https://www.fda.gov/premarket-notification-510k" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Premarket Notification 510(k)</a></p><p><a href="https://www.fda.gov/premarket-approval-pma" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Premarket Approval (PMA)</a></p><p><a href="https://www.fda.gov/files/about%20fda/published/CDRH-Learn---De-Novo-Program.pdf" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - De Novo Program</a></p><p><a href="https://www.fda.gov/media/132158/download" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - 513(g) Requests for Information</a></p><p><a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Medical Device User Fee Amendments (MDUFA) Reports</a></p><p><a href="https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Center for Devices and Radiological Health (CDRH)</a></p><p><a href="https://www.fda.gov/industry/regulated-products/medical-device-overview" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Medical Device Overview</a></p><p><a href="https://www.linkedin.com/in/michaeldrues" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Mike Drues on LinkedIn</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru</a></p>