In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment.

Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who’s responsible, and what industry and regulators can do to fix it.

Key Timestamps

[02:30] What is the MAUDE database, and why does it matter?
[06:10] The critical difference between reportable and non-reportable adverse events
[11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons
[17:45] Underreporting, late submissions, and missing data: The disturbing stats
[25:00] High-profile companies dominating late reporting violations
[32:10] Legal consequences: What expert witnesses look for in MAUDE data
[38:50] Is it poor systems or lack of regulatory understanding causing failures?
[46:00] Recommendations for manufacturers: What responsible reporting looks like
[53:20] How FDA could modernize the MAUDE database to better serve patients
[1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance
[1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill it

Standout Quotes

"A report in the MAUDE database is just a historical record. It doesn’t say why it happened or who’s at fault—just that it happened."

— Mike Drues

This quote underscores the limited utility of MAUDE reports and why interpretation requires caution.

"If you're not a medical device professional without your tools, then you're not really a medical device professional."

— Etienne Nichols

A poignant reminder that compliance and quality are human-led, not software-enabled by default.

Top Takeaways

Late Reporting is Widespread and Risky

Nearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm.

MAUDE Is Misused—Despite FDA Warnings

Manufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it.

Three Companies Account for Over Half of Late Reports

Large, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance.

Electronic Tools Help, but Culture Matters More

Software can support MDR timelines, but organizations still need internal processes and urgency to act responsibly.

FDA and Industry Both Need to Evolve

Suggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition.

References

FDA MAUDE Database
21 CFR 803.16 – MDR Reporting Requirements
Etienne Nichols on LinkedIn

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