# #341: What NOT to say to FDA

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-10-25
- Length: 49m
- Episode: 341
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda
- Listen: https://podcast.greenlight.guru/episode/341-what-not-to-say-to-fda

## Summary

Mike Drues, a regulatory consultant and expert witness, joins host Etienne Nichols to discuss strategies for communicating with the FDA during inspections and pre-market reviews. Drues emphasizes the mantra 'tell, don't ask, lead, don't follow' and advises companies to manage FDA expectations by providing objective evidence of their processes rather than just citing procedures. He highlights the importance of being prepared for unannounced inspections, answering only the question asked, and using clarifying questions to buy time when necessary.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=0) Introduction and Communication Philosophy
- [3:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=199) Managing Expectations and Avoiding Bad Answers
- [8:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=509) Anticipating Questions and Buying Time
- [11:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=707) FDA Inspection Triggers and Unannounced Visits
- [17:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=1051) Preparing for Inspections and Mock Audits
- [24:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=1479) Answering Strategies: Clarifying and Minimal Info
- [34:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=2062) Handling Problems and CAPA Discussions
- [43:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda#t=2632) Recap and Final Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- 510 K (other)
- PMA (other)
- de Novo (other)

## Related episodes from other shows

- [253 - FDA Is Making Big Changes to Its Inspection Approach](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach) (Let's Combinate)
- [219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness) (Let's Combinate)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)
- [087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-31-087-from-crime-reporting-to-regulatory-affairs-and-on-off-the-record-with-ferdou) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)

## Citing this page

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