U.S. FDA Proposes Medical Device Classification of Antimicrobial Wound Dressings and Liquid Wound Washes

The United States Food and Drug Administration (FDA) has proposed classifying certain wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, pre-amendment devices) as either Class II or Class III medical devices.

The FDA plans to create the following three classifications for wound dressings and liquid wound washes where the role of the antimicrobial is limited to acting within the dressing as a preservative or protectant of the product and not on the wound itself:

• Solid wound dressings containing antimicrobials and/or other chemicals
  • When the intended use is to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound.
• Wound dressings formulated as a gel, cream, or ointment containing antimicrobials and/or other chemicals
  • Where the intended use is to maintain appropriate moisture balance within the wound.
• Liquid wound washes
  • A water-based solution used to mechanically irrigate and physically remove debris from external wounds and to moisten solid wound dressings to maintain appropriate moisture balance within the dressing.

These products are currently unclassified devices that require 510(k) premarket notification and may fall under the product codes FRO, GER, MGP, MGQ, and EFQ for use on external cutaneous (skin) wounds. The FDA intends to make new product codes for the new classifications when this proposal is finalized.

Because the products are not achieving the primary intended purpose through chemical action within or on the body of man, the products should only be regulated as “devices” and not combination products. Products that have antimicrobials and/or other chemicals for “wound management” would not fall under the new product classifications. For example, wound dressings containing antimicrobials with certain wound management claims may be considered combination products or drugs. The proposed rule provides additional information on what claims may be considered “wound management” claims.

The proposed rule also provides the following definitions:

• Antimicrobial preservative
  • “An antimicrobial preservative is used in wound dressings formulated as a gel, cream, or ointment or liquid wound washes to maintain low bioburden while in its packaging during storage to improve its shelf life. An antimicrobial preservative use is not appropriate for a sterile, single-use product. Further, preservative effectiveness claims are within the scope of this proposed rule for the proposed classifications only when used for a specified period of use for multiple-use wound dressings and liquid wound washes for single patient only use.”
•  Antimicrobial protectant
  •  “An antimicrobial protectant, when added to a sterile, single-use solid wound dressing, is intended to support the use of the wound dressing by reducing degradation or biofouling of the dressing while in use. Antimicrobial protectant claims are within the scope of this proposed rule for the proposed classifications only when used for reducing microbial growth within the solid wound dressing for a specified maximum period of clinical use.”

The FDA plans to classify certain wound dressings and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III and would require premarket approval applications (PMAs). An antimicrobial is considered ‘medically important’ if it is found on the World Health Organization’s list of Critically Important Antimicrobials for Human Medicine: 6th Edition.

Meanwhile, certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern and/or other chemicals would be class II (subject to special controls and 510(k) requirements).

The following table is a List of Examples of Antimicrobials That Are Within the Scope of the Proposed Rule and the Proposed Classification Action for Certain Wound Dressings and Liquid Wound Washes that can be found in the proposed rule.

The proposed rule also provides some general information on how to support antimicrobial claims for wound dressings and liquid wound washes as well as how label claims should be worded and when the claims are appropriate.

Currently, there are more than 500 legally marketed unclassified, pre-amendment wound dressings and liquid wound washes containing antimicrobials and/or other chemicals that would be subject to this proposed classification regulation.

Effective Dates
If the proposed rule is finalized as it is currently written, products that are classified into Class III by this proposed rule will have 30 months to file a PMA with the FDA. If the PMA is not filed within 30 months, commercial distribution of the product must cease. “For currently marketed wound dressings and liquid wound washes that are proposed to be classified into class III, FDA is proposing in the above-mentioned proposed order that it does not intend to enforce compliance with the 30-month deadline by which PMAs must be submitted when a notice of intent to file a PMA is submitted within 90 days of the effective date of the order, if finalized. In circumstances when a notice of intent to file is submitted, FDA is proposing that it does not intend to enforce compliance with the 30-month deadline by which PMAs must be submitted when a PMA is submitted within 90 days after the 30-month deadline.”

Devices that are classified as class II that have not been offered for sale prior to the effective date, or have been offered for sale but are required to submit a new 510(k), the “FDA proposes that before
marketing these devices, manufacturers would have to obtain 510(k) clearance (unless exempted from 510(k)), and demonstrate compliance with the applicable special controls, within 6 months after the effective date of this rule, when finalized. After that date, if a manufacturer markets such a device without receiving 510(k) clearance, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.”

Class II devices that have prior 510(k) clearance, the FDA proposes that it would accept a new 510(k) and would issue a new clearance letter, as appropriate. “For the devices proposed to be classified into class II, subject to special controls as described in this proposed rule, FDA proposes that the special controls become effective 6 months after the effective date of the rule, when finalized. FDA proposes that if a manufacturer markets such a device 6 months after the effective date of the rule, when finalized, and that device does not comply with the special controls, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.”

Other Regulatory Updates
Additionally, if the proposed rule is finalized, the FDA plans to exempt liquid wound washes containing water or 0.9% saline only, which do not contain antimicrobials, other chemicals, or animal-derived materials from the 510(k) submission requirements.

The FDA is providing 90 days to comment on the proposed rule.

Link to the 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 Federal Register posting:

https://www.federalregister.gov/public-inspection/2023-26209/medical-devices-general-and-plastic-surgery-devices-classification-of-certain-solid-wound-dressings 

Link to the Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials Federal Register posting:

https://www.federalregister.gov/public-inspection/2023-26208/effective-date-of-requirement-for-premarket-approval-applications-for-certain-solid-wound-dressings
 

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