Hardware Podcasts

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

Global Medical Device Podcast · 21 Jul 2025 · 49m · Episode 415

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Greenlight Guru, FDA
Also
510(k), PMA, CAPA

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