
Global Medical Device Podcast powered by Greenlight Guru
#342: Planning an FDA Submission
Nov 2, 2023
Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, shares insights on FDA submissions for medical devices. She discusses different submission types, early FDA interactions, eSTAR system, and building relationships with review teams. Reynolds emphasizes preparation, organization, and proactive engagement with regulatory bodies for successful submissions.
38:53
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Quick takeaways
- Different types of FDA submissions for medical devices include 510(k), de novo, and PMA, each with unique requirements and approaches.
- Early engagement with the FDA through Q-Submissions, such as pre-submission meetings, is crucial for clarifying regulatory pathways and addressing questions.
Deep dives
Understanding FDA Submission Pathways
There are various types of submissions required by the FDA for medical devices. These include 510(k) submissions for devices with a substantially equivalent predicate, de novo submissions for novel devices without a clear predicate, and pre-market approval (PMA) submissions for class 3 devices that require clinical data. Additionally, there are early interactions with the FDA through Q-Submissions, such as pre-submission meetings and breakthrough device designation requests.
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