Episode 216  |  36:29 min  |  06.23.2021

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

00:00
00:00
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>

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 Pre-subs requested a meeting and one-third requested written email communication only.
  • On average, FDA takes two months to give a written response of approval or denial for a Pre-submission request.
  • A Pre-submission is completely optional and never required, but highly recommended.
  • 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.
  • Unlike 510(k) and PMA submissions, as well as 513(g) requests for information, there is no user fee associated with Pre-submissions.
  • When crafting a Pre-submission, justify reasons for why certain approaches are being taken over others.

Memorable Quotes from Mike Drues:

“A Pre-submission meeting is an opportunity to talk to the FDA before you actually make your submission.”

“Clearly, the popularity of the program is increasing.”

“A Pre-sub is purely optional. It is never required. A company can choose to do a Pre-sub or not.” 

“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.”

Links:

FDA - Q-Submission Guidance - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

FDA - Premarket Notification 510(k)

FDA - Premarket Approval (PMA)

FDA - De Novo Program

FDA - 513(g) Requests for Information

FDA - Medical Device User Fee Amendments (MDUFA) Reports

FDA - Center for Devices and Radiological Health (CDRH)

FDA - Medical Device Overview

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

More Episodes

Meet a Guru: Ryan Behringer

Navigating the MedTech Cybersecurity Ecosystem

Managing Clinical Data Activities

Explaining the Role of Importer under EU MDR

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development