In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns.

They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls.

This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.

Timestamps

00:04 – Introduction to common FDA compliance issues
02:02 – Discussion on FDA's policy of not naming individuals
05:45 – Mike Drues challenges the "pre-market" classification of common issues
09:20 – Documentation requirements for different device classes
11:35 – Mike’s take on the most common FDA issues (beyond the presented three)
15:40 – Root causes of common compliance problems and industry responsibility
20:00 – The role of regulation and FDA's responsibility in clarity
27:05 – Deep dive into design change and design creep
31:40 – Software changes and the "bug fix" mentality
35:45 – Marketing beyond authorized intended use with a real-world example
41:00 – Key takeaways and proactive compliance strategies

Standout Quotes

"If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules.
"You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.

Top Takeaways

Regulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.
Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).
Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.
Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.
Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.

References & Links

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

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