Planning an FDA Submission

November 2, 2023


In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the complexities of FDA submissions for medical devices.

Ellie sheds light on the nuances of different submission types, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS).

Listeners are guided through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Ellie's expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.

Listen now:

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Some of the highlights of this episode include:

  • Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.
  • Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.
  • Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.
  • The importance of understanding and managing FDA review timelines, including potential pauses and extensions.
  • How utilizing eSTAR helps identify documentation gaps and assess submission readiness.
  • How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.
  • The importance of comprehensive preparation and organization facilitate expedited FDA review, despite uncontrollable factors. 


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Memorable quote:

"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie Reynolds

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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