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.

• [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] Final recommendations: Testing the efficacy of your device description.

1. Mike Drues: "If the FDA doesn’t understand your device, it’s not their fault—it’s the manufacturer’s responsibility to communicate effectively."
2. Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection."
3. Mike Drues: "A picture’s worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly."

1. Clear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices.
2. Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification.
3. Visual aids, like images and videos, are becoming standard tools to enhance submissions.

1. Test your description’s efficacy by asking someone unfamiliar with the device to explain it back to you.
2. Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists.
3. Incorporate visuals or videos to clarify complex mechanisms or testing processes.

1. How might advancements in AI reshape the expectations for device descriptions?
2. Could the FDA eventually require interactive or multimedia submissions as standard?
3. What new tools or technologies can help manufacturers streamline the description-writing process?

• Greenlight Guru: Purpose-built quality management systems for MedTech. Learn more.
• Stephen Covey: Seven Habits of Highly Effective People—inspiration for improving communication practices.
• Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now.

What is a device description?

A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes:

• Anatomy: Components and materials.
• Physiology: Function and mechanism of action (MOA).
• Pathology: Risks or potential failures.

Why it matters:

• Guides regulatory classification and testing requirements.
• Establishes a clear understanding for reviewers, ensuring smooth approval processes.

Poll Question:

What challenges have you faced in creating a device description?

• Ambiguity in regulatory expectations
• Balancing technical detail with simplicity
• Miscommunication with reviewers
• Other (email us at [email protected])

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Sponsor:

This episode is brought to you by Greenlight Guru, the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.