The FDA’s Proposed Rule on the Classification of Wound Dressings

by | Jun 10, 2024 | 510k, Compliance, FDA, Global Leader, GMP, Medical Devices, PMAs, Regulatory, Remediation

In November of last year, the FDA proposed a new rule aimed at revising the classification of wound dressings. This rule is expected to bring significant changes to how these medical devices are regulated, impacting manufacturers, healthcare providers, and patients alike. This blog will discuss what this proposed rule entails, its implications, and the rationale behind it.

Wound dressings are medical devices used to cover and protect wounds, aiding in the healing process by maintaining a moist environment, protecting from infection, and sometimes delivering medication directly to the wound site. They range from simple bandages to advanced products with antimicrobial properties or integrated sensors.

Under the current FDA framework, wound dressings are classified based on their intended use and complexity. The classifications include:

  • Class I (General Controls): Includes simple dressings such as gauze pads.
  • Class II (General and Special Controls): Includes more complex dressings like those with antimicrobial agents.
  • Class III (Premarket Approval): Used for highly advanced dressings that significantly impact the body’s structure or function.

The FDA’s proposed rule aims to refine these classifications to better reflect technological advancements and clinical needs. Key elements of the proposal include:

  • Reclassification of Certain Products: Some advanced dressings currently classified as Class II may be reclassified as Class III due to their complexity and potential impact on patient health. Specifically, wound dressings and liquid wound washes containing medically important antimicrobials would become Class III due to their high level of antimicrobial resistance (AMR). Further to that, wound dressings/liquid wound washes containing antimicrobials with a medium/low level of AMR concern would be classified as Class II.
  • New Subcategories: Introduction of new subcategories within the existing classes to provide more precise regulation tailored to specific types of wound dressings.
  • Enhanced Pre-market Review: Increased scrutiny for products with novel technologies, ensuring they meet rigorous safety and efficacy standards before approval. The up classification of certain types of wound care devices will force device manufacturers to follow either the PMA or 510(k) pathways in order to market their product.
  • Post-market Surveillance: Strengthened requirements for post-market surveillance to monitor the long-term safety and effectiveness of wound dressings.

The reclassification may necessitate additional testing and documentation, potentially increasing time and costs associated with bringing new products to market. However, it could also streamline the approval process for certain products, fostering innovation. Ultimately, the proposed rule aims to ensure that patients have access to safe and effective wound dressings, potentially improving outcomes and reducing complications.

The FDA’s initiative is driven by several factors:

  1. Technological Advances: Rapid innovation in wound care technologies necessitates updated regulatory frameworks.
  2. Patient Safety: Ensuring that new and complex wound dressings are rigorously evaluated to prevent adverse events.
  3. Market Evolution: Adapting to the evolving landscape of medical devices to support industry growth while maintaining high standards of public health protection.

The FDA has opened the proposal to public comment, encouraging feedback from industry stakeholders, healthcare professionals, and the general public. This collaborative approach aims to refine the rule based on practical insights and concerns, ensuring it effectively balances innovation with safety.

The FDA’s proposed rule on the classification of wound dressings represents a proactive step toward modernizing wound care medical device regulation in response to technological and clinical advancements. By refining the classification system, the FDA aims to enhance patient safety, support innovation, and ensure the availability of effective wound care solutions.

Do you need help navigating this proposed rule and how it may impact your product? Reach out to the medical device regulatory experts at EMMA International for help! Call us at 248-987-4497 or email to learn more.

FDA (Nov 2023) Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes RIA (Proposed Rule) retrieved from:

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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