Hardware Podcasts

#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures

Global Medical Device Podcast · 9 Jun 2025 · 50m · Episode 410

What this episode covers

Regulatory expert Mike Drues joins host Etienne Nichols to critique the FDA’s MAUDE database, arguing that widespread late reporting and poor data hygiene undermine its safety mission. Drues highlights that nearly 30% of reports are late, with major manufacturers like Medtronic, Becton Dickinson, and Dexcom accounting for a disproportionate share of violations. The discussion covers the legal risks of non-compliance, the misuse of MAUDE data for competitive analysis, and recommendations for modernizing the system with AI-driven cross-referencing and tiered reporting urgency.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Medtronic, Becton Dickinson, Dexcom, BioHorizons, Greenlight Guru, Phillips Respironics
Tools
MAUDE

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