#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development.

They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.

Key Timestamps:

• [02:30] – Introduction to Sarah Moeller and her role in ISO 18969 updates.
• [07:00] – Overview of ISO standards update processes and FDA’s critical role.
• [15:20] – The impact of AI and digital evidence on clinical evaluations.
• [22:10] – Why FDA's temporary absence from standards writing matters.
• [31:45] – Resumed communications: FDA’s current engagement status.
• [41:00] – Implications of leadership changes at the FDA.
• [50:15] – Strategic advice for MedTech companies amidst regulatory uncertainty.
• [58:00] – Passionate case for FDA's continued involvement and defense of public service.
• [1:12:30] – Big updates in ISO 14155 and 18969 and what they mean for clinical trials.

Memorable Quotes:

• "Without FDA at the standards table, we risk global disharmony—and patients pay the price." – Sarah Moeller
• "Taking care of each other must be our number one goal in both hospitality and healthcare." – Sarah MoellerKey Takeaways:

Practical Tips:

1. Maintain proactive and open communications with your FDA reviewers.
2. Incorporate rigorous digital evidence management to future-proof clinical evaluations.
3. Advocate for clear regulatory processes by contacting your congressional representatives.

References Mentioned:

• ISO 14155: Good Clinical Practice for Medical Device Trials—Updated to reflect decentralized trials and enhanced CRO oversight.
• ISO 18969: Clinical Evaluation Standard aligning evaluations across the total product lifecycle.
• MDUFA and PDUFA: Critical funding mechanisms supporting timely FDA review processes.
• Etienne Nichols on LinkedIn

MedTech 101:

ISO Standards: International standards that ensure quality, safety, and efficacy in products across global markets.

MDUFA (Medical Device User Fee Agreement): Agreement where companies pay fees to FDA for timely device reviews.

Clinical Evaluation: Systematic process for assessing and analyzing clinical data to verify the safety and performance of a medical device.

Audience Interaction:

Poll Question: "Do you believe the FDA should have a permanent seat at all ISO standards committees?"

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Sponsor Mention:

Brought to you by Greenlight Guru Quality:

Greenlight Guru helps MedTech companies stay audit-ready 24/7 with smarter, structured quality management tools that align with FDA and ISO requirements. Visit www.greenlight.guru to learn how your team can innovate faster while staying compliant.