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In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators.Key Timestamps[00:01] Introduction: Why device descriptions are foundational for regulatory submissions.[07:15] Common challenges: Why device descriptions are often poorly written.[14:30] Purpose and impact: How descriptions influence classification, testing, and approval pathways.[25:45] Practical advice: Balancing simplicity with technical detail for diverse audiences.[36:10] Pre-sub meetings: Communicating device descriptions effectively with the FDA.[50:30] Fina