Live! #79 – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut

Device Advice by RQM+

This was recorded 6 June 2024. We encourage you to download the presentation slides by ⁠⁠⁠completing the form on this page⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠ or ⁠⁠⁠⁠Events⁠⁠⁠⁠ pages at RQMplus.com.

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Summary

The conversation discusses the proposed rule by the FDA for wound care devices and its potential impact on the industry. The panelists highlight the importance of wound care and the need for regulations to protect public health. They also discuss the concerns and criticisms surrounding the proposed rule, including the lack of scientific evidence supporting the need for reclassification. The panelists address questions about the criteria for classification, the impact on innovation and product availability, and the timeline for finalizing the rule. Overall, the conversation emphasizes the importance of balancing regulatory requirements with the need for innovation and patient care. The conversation focused on the proposed rule change by the FDA regarding wound care products and the potential impact on the industry. The participants discussed the concerns and challenges related to additional testing requirements, product classification changes, and labeling requirements. They also explored the potential opportunities for innovation in wound care. The conversation highlighted the need for collaboration between industry and the FDA to address the concerns and find a balance between patient safety and regulatory requirements.

Takeaways

• The proposed rule by the FDA for wound care devices has raised concerns and criticisms within the industry.
• There is a lack of scientific evidence supporting the need for reclassification and the proposed rule's impact on innovation and product availability.
• The FDA's focus on antimicrobial resistance is a key concern, but the panelists question the scientific rationale behind the proposed rule.
• The timeline for finalizing the rule is estimated to be one to two years, with potential legal challenges expected.
• Balancing regulatory requirements with the need for innovation and patient care is crucial in the wound care industry. The proposed rule change by the FDA regarding wound care products has raised concerns and challenges for the industry.
• Additional testing requirements are a major concern for manufacturers, as they can be costly and time-consuming.
• Product classification changes, particularly being bumped into the PMA category, can have significant implications for manufacturers.
• Collaboration between industry and the FDA is crucial to address concerns and find a balance between patient safety and regulatory requirements.
• There may be potential opportunities for innovation in wound care, particularly in the development of technologies that address antimicrobial resistance.
• It is important for manufacturers to stay informed, engage with the FDA, and be prepared for potential changes in regulations.

Chapters

00:00 Introduction and Overview

04:04 Why Wound Care Matters

17:36 Impact on Innovation and Product Availability

28:20 Wound Prevention and Patient Impact

31:09 Scientific Evidence and Concerns

34:47 Proposed Rule Changes and Societal Impact

35:46 Challenges of Showing AMR Clinically

37:43 Pretextual Changes and Labeling

39:49 Exploring Other Technologies for AMR Concerns

42:05 Concerns and Poll Results

51:51 Working with FDA and Closing

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