The Ruling
On November 30, 2023, the United States (US) Food and Drug Administration (FDA) released a proposed rule to up-class certain wound care products. Specifically, this proposal would affect solid wound dressings, wound dressings formulated as a gel, cream or ointment, and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern. Currently, many of these products are considered unclassified. For any products that are affected by the ruling, if passed, a premarket approval application (PMA) would now be required, and those products would be considered Class III medical devices. The proposal will be open to comments until February 28, 2024.
View the official document here.
Wound Care History
Wound care devices have been the topic of discussion in the past. There have been reviews and panel meetings about these devices in 1998, 2005, and 2016. In the most recent meeting in 2016, there was similar discussion regarding up classing these devices again based on the benefits and the risks of the products. However, during that meeting, the final decision was that the products should be Class II for the majority of the devices.
What Products are Affected?
As indicated above, the proposal is applicable to solid wound dressings, wound dressings formulated as a gel, cream or ointment, and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern. However, for each of these types of products, there are specific functionalities that have been defined, which may exclude some of the products on the market.
Solid wound dressings must contain antimicrobials and/or other chemicals. Additionally, the intended use would be to cover and/or protect the wound, maintain the wound’s moisture and to absorb exudate from the wound.
Gels, creams, and ointments are used as a wound dressing and contain antimicrobials and/or other chemicals. These products are intended to maintain moisture within the wound.
Liquid wound wash is used to irrigate the wound and remove any debris from the wound. This can also be used to moisten solid wound dressings.
For all these products, the antimicrobial and chemical ingredients are in place to act as a preservative, inhibit microbial growth within the product and add to the shelf life of the product. They are not intended to act as antimicrobials within the wound or prevent infection of the wound.
It’s All About the Risk
According to the FDA, there are inherent risks associated with these types of products identified through their use. After reviewing the listed risks and adverse events, the FDA determined that the PMA process was necessary to ensure the safety of the public.
By means of Medical Device Reports issued between 1994 and 2022, the FDA was able to identify the following risks / adverse events for each of the product types*:
| Adverse tissue reaction | Immunological reaction | Transmission of pathogens and parasites |
| Toxicity | Delayed wound healing | Incompatibilities with other therapies |
| Contribution to the spread of AMR | Infection | Microbial growth within the product |
| Product degradation during stated shelf storage | Loss of barrier function | Retention of dressing material in the wound |
| Negatively impacting the skin microbiota in the peri-wound area resulting in impaired wound healing |
*FDA Proposed Rule FDA-2023-N-3275
Each of the above risks can affect the user's health, and the detailed risk and its health effect can be further investigated by reading the proposal in full.
To make the matter more challenging, based on the applicable product market applications, the FDA cannot site any clinical evidence to substantiate any claimed clinical benefits.
The PMA Process The premarket approval process is a well-established process within the FDA. The FDA Code of Federal Regulations (CFR) Title 21, Part 814 outlines the process and the requirements of creating and submitting a PMA. However, these are significant differences from the 510(k) process.
The PMA application should include scientific and clinical data to demonstrate the effectiveness and safety of the product. As part of the proposed rule, the FDA recommends that the PMA should include performance testing and data. This includes the full reports of any applicable clinical investigations. Additionally, the PMA should also include any known risks associated with the product.
What is the Next Step? As indicated above, the proposed rule is currently in the comment phase. However, there is a favorable chance that the rule will be ratified as written. Assuming that will be the case, there is a window for companies to gain compliance with the new rule. As part of the rule, the FDA has indicated that it does not intend to enforce the rule for a thirty (30) month period. Any appliable product will need to have a PMA submitted for review and approval before the 30-month window expires. That window can also be extended another 90 days if a notice of intent to file is submitted, and the PMA is submitted within 90 days after the expiration of the 30-month period. For any applicable products that do not meet this timeline, the expectation is that those devices will not be further distributed into the market.
For new devices, the standard PMA process would apply.
Conclusions If your company has any of the devices outlined in this article, feel free to
contact Qserve to assist you with any questions related to this proposed rule or to assist with any changes to your product submission. Qserve has quality and regulatory experts throughout the world to assist with market entry, quality system management, and regulatory submissions.