# #342: Planning an FDA Submission

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-11-02
- Length: 38m
- Episode: 342
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission
- Listen: https://podcast.greenlight.guru/episode/342-planning-an-fda-submission

## Summary

Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, explains the strategic planning required for FDA medical device submissions. She details the differences between 510(k), De Novo, and PMA pathways, emphasizing the critical role of Q-submissions (pre-submissions) and the eSTAR system in identifying documentation gaps early. Reynolds highlights the importance of realistic timeline management, including the 60-75 day wait for pre-sub meetings and potential review pauses, as well as navigating user fees and building collaborative relationships with FDA review teams.

## Chapters

- [0:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=57) Introduction and Submission Pathways
- [4:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=282) Timelines and Review Pauses
- [10:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=629) Using eSTAR to Identify Gaps
- [12:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=743) Conducting Q-Submissions and Pre-Sub Meetings
- [22:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=1330) Building Relationships with FDA Reviewers
- [26:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=1619) User Fees and Small Business Determinations
- [32:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission#t=1966) Timeline Realities and Cross-Functional Collaboration

## 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

- Proxima Clinical Research (company)
- FDA (other)
- eSTAR (tool)
- Greenlight Guru (company)

## Related episodes from other shows

- [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)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w) (Let's Combinate)
- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (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/2023-11-02-342-planning-an-fda-submission. 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.