What NOT to say to FDA

October 26, 2023


In this comprehensive episode, Etienne Nichols and Mike Drues dive into the enlightening world of FDA inspections.

The duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA.

They reveal insights that every MedTech professional must know, breaking down the philosophy, challenges, and expectations surrounding inspections, all while blending unique "Mike Drues isms" and Etienne's candid takes.

Listen now:

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Some of the highlights of this episode include:

  • Grasping the art of proactive communication with the FDA, laying the foundation for regulatory success.

  • Delving into the essence of managing FDA's expectations during pivotal conversations.

  • Exploring the unpredictability of FDA inspections and the mantra of always being prepared.

  • Differentiating between inspections for class two/lower medical devices and class three devices.

  • Unpacking the role of FDA registration in attracting the FDA's attention for inspections.

  • Achieving the perfect equilibrium when providing information during inspections.

  • Navigating through concerns raised by FDA reviewers and appreciating the value of swift responses.

  • Addressing the nuanced gray areas, ranging from "sufficient investigation" to acknowledging and rectifying errors.

  • Unveiling real-world scenarios where complaints in medical device manufacturing are addressed effectively.


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Memorable quote:

""The solution to most problems is more communication, not less." - Mike Drues

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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