In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices.
She 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).
Reynolds also guides listeners through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Her expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.
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.
"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie Reynolds
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