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."

MedTech Trends

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.

Practical Tips

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.

Future Questions

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...

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development.

They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.

Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.

• [02:30] – Introducing Leo Eisner and his expertise in IEC 60601 and global standards.
• [06:45] – The complexities of updating IEC 60601 and its 12 working groups.
• [12:20] – Expected timeline for the fourth edition (2029-2030) and why companies need to plan now.
• [18:50] – Overview of the most significant upcoming changes, including wireless coexistence and integration of collateral standards.
• [27:00] – Practical advice for navigating new standards during product development.
• [36:15] – How to engage in the standards development process and submit comments.
• [48:30] – Benefits of proactive planning and test preparation for regulatory success.
• [53:45] – The importance of staying informed and embracing continuous learning in MedTech.

1. "The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner
2. "IEC 60601 is often thought of as just an electrical standard, but it’s so much more—it’s about mitigating risks across all aspects of a device." – Leo Eisner
3. "Standards aren’t just rules; they’re lessons learned from history, guiding us to safer, better devices." – Etienne Nichols

Latest Trends in MedTech Standards

1. The modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations.
2. Wireless coexistence and other cutting-edge technologies will soon become international requirements.
3. Consolidating collateral standards improves consistency and reduces redundancies.

Practical Tips for Compliance

1. Begin designing for new standards early, even before they are finalized.
2. Stay informed by engaging with industry groups and standards organizations.
3. Use test planning to streamline development and meet regulatory expectations efficiently.

Questions to Ponder for the Future

1. How will integrating advanced hazard mitigation strategies impact device innovation?
2. What role will emerging technologies like AI and IoT play in future standards revisions?
3. How can smaller MedTech companies effectively adapt to these significant changes?

For new listeners, IEC 60601 is a global standard that ensures the safety and effectiveness of medical electrical equipment. It encompasses requirements for design, labeling, testing, and risk management. With updates spanning usability, wireless technologies, and biocompatibility, it’s essential for any MedTech company working with electrical devices.

• Greenlight Guru – The QMS software designed exclusively for MedTech: Learn more
• Connect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601:

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices.

They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway.

Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data.

With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.

• 00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message
• 03:15 – Introduction to Dr. Mike Drues and his background in PMAs
• 05:45 – Overview of PMAs and when they should be used
• 11:30 – Are PMAs the only pathway for Class 3 devices?
• 16:20 – Types of PMAs: Traditional, Modular, and Streamlined
• 22:40 – Advantages of PMAs compared to 510(k)s and de novos
• 27:50 – The strategic use of predicates in the PMA process
• 33:00 – Clinical data requirements and misconceptions for PMAs
• 41:10 – Post-market requirements and differences for PMA devices
• 47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals
• 54:30 – Final thoughts on overcoming industry resistance to PMAs

1. "Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues
2. "Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues

1. PMA Isn’t the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden.
2. Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market.
3. Clinical Data Isn’t Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies.

• Previous Greenlight Guru Webinars by Dr. Mike Drues
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements.

Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you...