Last week, FDA proposed two new rules to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations:
- Solid wound dressings: this covers products intended to cover and protect a wound against external contamination, to absorb exudate and to maintain appropriate moisture balance within the wound (e.g. traumatic wounds, ulcers or surgical wounds)
- Wound dressings formulated as a gel, cream or ointment: this covers products intended to provide or support a moist wound environment; and
- Liquid wound washes: intended to rinse or irrigate a wound to remove foreign material such as debris and wound exudate. and physically remove debris from external wounds
FDA is proposing classification for solid wound dressings to be a split classification.
For Class II, the FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of antimicrobial resistance (AMR) and/or other chemicals into Class II. These devices would be subject to special controls and premarket notification requirements, in addition to general controls. The FDA is proposing that manufacturers will need to demonstrate compliance with applicable special controls within six months after the effective date of the rule, when finalized.
For Class III wound products that contain substances (drugs or other chemicals) that have a high level of AMR the FDA is proposing to require that manufacturers file a premarket approval application (PMA).
Currently, FDA regulates these unclassified devices as devices requiring premarket notification (510(k) requirements) but the Agency is seeking to create new product codes for these proposed classifications once the proposed rule is finalized. While these products may have been previously identified as combination products, FDA believes that with clarification of the intended use claims, wound dressings and liquid wound washes, including those with antimicrobials, should be regulated only as devices and not as combination products.
Additionally, FDA advises that wound dressings and liquid wound washes that do not contain a component that achieves a primary intended purpose of the product through chemical action within or on the body are considered devices, even if these products contain components that are regulated as drugs in other contexts.
Due to perceived patient risk and heightened concern over increased antimicrobial resistance, the Agency’s proposed new and potentially far-reaching framework supports added regulation over medical devices that contain antimicrobial substances and is set to change the regulatory status of many existing products.
We recommend that manufacturers of wound care products that incorporate antimicrobials or other chemicals conduct a product analysis to determine whether the proposed rule impacts operations and to determine whether current marketing authorizations are adequate or require additional or new approvals.
FDA is seeking comments on the proposed medical device classification through February 8, 2024.
