Artwork for podcast Global Medical Device Podcast powered by Greenlight Guru
#341: What NOT to say to FDA
Episode 34125th October 2023 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs
00:00:00 00:49:10

Share Episode



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

Some of the highlights of this episode include:

  1. Grasping the art of proactive communication with the FDA, laying the foundation for regulatory success.
  2. Delving into the essence of managing FDA's expectations during pivotal conversations.
  3. Exploring the unpredictability of FDA inspections and the mantra of always being prepared.
  4. Differentiating between inspections for class two/lower medical devices and class three devices.
  5. Unpacking the role of FDA registration in attracting the FDA's attention for inspections.
  6. Achieving the perfect equilibrium when providing information during inspections.
  7. Navigating through concerns raised by FDA reviewers and appreciating the value of swift responses.
  8. Navigating the nuanced gray areas, ranging from "sufficient investigation" to acknowledging and rectifying errors.
  9. Unveiling real-world scenarios where complaints in medical device manufacturing are addressed effectively.


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

Reference Links:

*Interested in sponsoring an episode? Use this form and let us know!