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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-06-23
- Length: 36m
- Episode: 216
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see
- Listen: https://podcast.greenlight.guru/episode/preparing-your-pre-submission-with-the-content-fda-wants-to-see

## Summary

Mike Drues, a regulatory consultant for Vascular Sciences, explains the strategic preparation of FDA Pre-submissions (Q-submissions) to mitigate the high first-time rejection rates of 510(k) and PMA applications. He argues that companies should treat the FDA as an equal partner rather than a teacher, using Pre-subs to justify both the proposed regulatory pathway and the testing matrix. Drues emphasizes that success requires leading the witness by framing questions to demonstrate why a specific approach is correct, rather than simply asking for approval. The episode highlights that ignoring this strategic communication often leads to costly delays and major deficiency letters.

## Chapters

- [1:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=92) Introduction: Mike Drues and Vascular Sciences
- [2:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=140) Pre-Submission Statistics and Volume
- [5:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=306) Optional Nature and Rejection Rates
- [8:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=519) Cost, Meetings, and COVID Impacts
- [16:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=967) Defining Success and Content Requirements
- [20:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=1210) Leading the Witness and Question Strategy
- [25:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=1522) Three Core Objectives: Strategy, Testing, Clinical
- [33:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see#t=1986) Final Advice: Tell Don't Ask

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- 510(k) (other)
- PMA (other)
- De Novo (other)

## Related episodes from other shows

- [219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness) (Let's Combinate)
- [084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-10-084-drug-discovery-candidate-selection-pre-clinical-development-ind-submissions) (Let's Combinate)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.