Hardware Podcasts

#456: What You Don’t Know Can Hurt You: 483 Pitfalls and Regulatory Accountability

Global Medical Device Podcast · 20 Apr 2026 · 53m · Episode 456

What this episode covers

Mike Drues, an industry veteran with over 30 years of experience, joins host Etienne Nichols to discuss the dangers of 'boneheaded' regulatory mistakes in MedTech, specifically focusing on the non-delegable responsibility of manufacturers. They analyze the first FDA warning letter issued for GMP violations related to AI, where a company used AI to generate specifications without process validation, arguing that AI cannot replace human judgment or the Quality Unit. The conversation extends to the debate on individual accountability in warning letters, the distinction between wellness and regulated devices, and new FDA programs like the TEMPO pilot and Breakthrough Device Designation (BDD).

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Pure Parolia, Recovery AI
Also
Mike Drues, Etienne Nichols, FDA, TEMPO, BDD, STEP

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