# #416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-07-21
- Length: 49m
- Episode: 415
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-21-416-unpacking-common-fda-compliance-gaps-pre-market-vs-post-market-realities
- Listen: https://podcast.greenlight.guru/episode/416-mike-drues

## Summary

Mike Drues, a regulatory consultant and former FDA subject matter expert, joins host Etienne Nichols to critique the FDA's recent identification of 'lack of documentation for software changes,' 'design creep,' and 'marketing beyond authorized intended use' as top pre-market compliance issues. Drues argues these are fundamentally post-market problems, highlighting that 75% of 510(k) submissions are rejected initially, primarily due to substantial equivalence failures, while post-market 483s frequently cite CAPA, design controls, and complaint handling. The discussion emphasizes that regulatory professionals must exercise individual accountability and technical judgment rather than blindly following bureaucratic mandates, using a specific example of a company marketing an MRI software for Alzheimer's diagnosis despite its clearance only for brain structure segmentation.

## Outline

1. Introduction and FDA Policy Critique
2. Pre-Market vs. Post-Market Misclassification
3. Root Causes and Regulatory Philosophy
4. Design Change and Design Creep
5. Software Bug Fixes and Validation
6. Marketing Beyond Intended Use Example
7. Key Takeaways and Professional Accountability

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- 510(k) (other)
- PMA (other)
- CAPA (other)

## Related episodes from other shows

- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-21-416-unpacking-common-fda-compliance-gaps-pre-market-vs-post-market-realities. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.