{"id":201,"date":"2024-06-06T11:32:00","date_gmt":"2024-06-06T16:32:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&p=201"},"modified":"2025-06-05T15:47:45","modified_gmt":"2025-06-05T20:47:45","slug":"rsvp-live-79-fda-wound-care-shakeup","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/rsvp-live-79-fda-wound-care-shakeup\/","title":{"rendered":"FDA’s Wound Care Shakeup: Ensuring Your Products Make the Cut"},"content":{"rendered":"\n
\"recorded<\/figure>\n\n\n\n

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. <\/p>\n\n\n\n

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. <\/p>\n\n\n\n

In addition to your questions (please attend live so you can ask!) we’ll cover:<\/p>\n\n\n\n

    \n
  1. Impact Assessment<\/strong>:\u00a0Our experts will break down the key aspects of the proposed rule, including changes to product classification, labeling requirements, and\u00a0testing.\u00a0We’ll\u00a0help you\u00a0determine\u00a0if your wound care product may be subject to a 510(k) or PMA under the new rule.\u00a0Our expert panel has extensive experience with FDA submissions and can help you understand what may be needed moving forward.
    <\/li>\n\n\n\n
  2. Labeling Implications<\/strong>:\u00a0We’ll\u00a0discuss 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.
    <\/li>\n\n\n\n
  3. Additional Testing Requirements<\/strong>:\u00a0We’ll\u00a0explore the potential for\u00a0additional\u00a0testing that may\u00a0be applicable\u00a0to your wound care product under the new rule. Our experts will provide guidance on how to prepare for and meet these requirements.
    <\/li>\n\n\n\n
  4. Industry Feedback<\/strong>:\u00a0We’ll\u00a0review and discuss the comments\u00a0submitted\u00a0by 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.<\/li>\n<\/ol>\n\n\n\n

    By attending this discussion, you’ll gain a comprehensive understanding of the proposed wound care products rule and its potential impact on your business. <\/p>\n\n\n\n

    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. <\/p>\n\n\n\n

    Please complete the form to watch the recording and download the slides.<\/p>\n\n\n\n

    Panelists:<\/p>\n\n\n\n

      \n
    • Mark DuVal \u2013 President & CEO, DuVal & Associates, P.A.<\/li>\n\n\n\n
    • Allison Komiyama, Ph.D., RAC\u00a0\u2013 Vice President, MedTech Innovations, RQM+<\/li>\n\n\n\n
    • Jon Gimbel, Ph.D. \u2013 Vice President of Technical, RQM+<\/li>\n\n\n\n
    • Erin Gontang \u2013 Senior Consultant, RQM+<\/li>\n\n\n\n
    • Jaishankar (Jai) Kutty, Ph.D. \u2013 Vice President, Global Regulatory Affairs, RQM+ (moderator)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

      The FDA’s recently proposed rule on wound care products has sent ripples through MedTech. This rule, if finalized, could significantly…<\/p>\n","protected":false},"author":2,"featured_media":161,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[9],"class_list":["post-201","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"FDA’s Wound Care Shakeup: Ensuring Your Products Make the Cut","link":"https:\/\/www.rqmplus.com\/resources\/rsvp-live-79-fda-wound-care-shakeup\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/philippe-spitalier-kA9901YPOCk-unsplash-Copy-min.jpg","excerpt":"The FDA’s recently proposed rule on wound care products has sent ripples through MedTech. 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