FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates.

They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes.

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Key timestamps

• [00:00] - Introduction to the episode and guests
• [02:15] - Overview of Greenlight Guru's QMS software
• [04:30] - Introduction to the FDA's proposed rule on wound dressings
• [06:00] - Mark DuVal discusses the broad implications of the proposed rule
• [12:45] - Kathy Herzog explains the performance requirements and administrative record
• [22:00] - Discussion on industry response and potential litigation
• [30:30] - Impacts on existing and new products in the market
• [40:20] - Strategies for companies to navigate the proposed changes
• [50:00] - Broader implications for the FDA and potential future regulations
• [60:00] - Final thoughts and ways to stay informed

Top takeaways from this episode

1. The FDA's proposed rule could significantly impact the classification and regulation of wound dressings.
2. There is substantial industry opposition to the proposed rule, with many companies and trade associations voicing their concerns.
3. The broader implications of the FDA's actions suggest a shift towards more aggressive regulatory measures.

Practical tips for MedTech professionals

1. Stay informed about regulatory changes and participate in comment periods to voice concerns.
2. Prepare for potential new testing and data requirements by reviewing current performance testing protocols.
3. Engage with industry groups and legal experts to understand the full impact of proposed regulations.

MedTech 101

• Classification of Medical Devices: Medical devices are classified into three categories based on their risk level: Class I (low risk), Class II (moderate risk), and Class III (high risk). The FDA's proposed rule aims to classify certain wound dressings, potentially impacting their regulatory requirements.

• 510(k) Clearance: A premarket submission to the FDA demonstrating that the device to be marketed is at least as safe and effective, substantially equivalent, to a legally marketed device.

Related links

• Greenlight Guru QMS Software
• FDA Proposed Ruling on Wound Dressings
• DuVal & Associates Client Alert on FDA Proposed Rule
• Alliance of Wound Care Stakeholders
• Washington Legal Foundation
• Connect with Etienne Nichols on LinkedIn 

Memorable quotes from this episode

• "This proposed rule feels like a solution in search of a problem." - Mark DuVal
• "It's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing." - Kathy Herzog
• "FDA's move to over-regulate well-settled product categories is deeply concerning." - Mark DuVal

Audience feedback

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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