Hardware Podcasts

#341: What NOT to say to FDA

Global Medical Device Podcast · 25 Oct 2023 · 49m · Episode 341

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, 510 K, PMA, de Novo

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