The FDA's recently proposed rule on wound care products has sent ripples through MedTech. This rule, if finalized, could significantly impact the classification, labeling, and testing requirements for a wide range of wound care devices. This online panel is your key to understanding the potential implications of this rule on your products and to prepare for the changes.
In this conversation, our team of FDA regulatory experts will examine the proposed rule, providing valuable insights and actionable strategies to help you navigate what's next for wound care devices.
In addition to your questions (please attend live so you can ask!) we'll cover:
- Impact Assessment: Our experts will break down the key aspects of the proposed rule, including changes to product classification, labeling requirements, and testing. We'll help you determine if your wound care product may be subject to a 510(k) or PMA under the new rule. Our expert panel has extensive experience with FDA submissions and can help you understand what may be needed moving forward.
- Labeling Implications: We'll discuss the potential impacts on label claims and how they may affect the classification of your wound care product. Our experts will also provide guidance on how to adapt your labeling to ensure compliance with the new requirements.
- Additional Testing Requirements: We'll explore the potential for additional testing that may be applicable to your wound care product under the new rule. Our experts will provide guidance on how to prepare for and meet these requirements.
- Industry Feedback: We'll review and discuss the comments submitted by manufacturers, trade associations, and clinical associations during the rule's comment period. Understanding the concerns and perspectives of industry stakeholders will be key in developing effective strategies for compliance.
By attending this discussion, you'll gain a comprehensive understanding of the proposed wound care products rule and its potential impact on your business.
You'll walk away with practical strategies and actionable insights to help you ensure compliance, maintain market access, and continue delivering innovative wound care solutions to patients in need.
Please complete the form to watch the recording and download the slides.
Panelists:
- Mark DuVal – President & CEO, DuVal & Associates, P.A.
- Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovations, RQM+
- Jon Gimbel, Ph.D. – Vice President of Technical, RQM+
- Erin Gontang – Senior Consultant, RQM+
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)
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