This proposed rule, if finalized, would classify certain types of currently unclassified wound dressings and liquid wound washes containing antimicrobials and/or other chemicals: solid dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes. FDA is proposing to classify wound dressings and liquid wound washes containing medically important antimicrobials into class III due to their high level of antimicrobial resistance (AMR) concern, for which FDA is separately proposing to require the filing of a PMA. FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for such wound dressings and liquid wound washes. In addition, FDA is proposing to classify wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern into class II subject to general and special controls. 

The quantifiable benefits of the proposed rule, if finalized, accrue to manufacturers of wound dressings and liquid wound washes and FDA. These benefits are the result of clarifications in the 510(k)-submission process, specifically defined regulatory classification, and published special controls. This additional clarity in requirements should result in fewer additional information submissions to FDA. We estimate annualized cost savings ranging from approximately $1.12 million to $6.31 million at a 3 percent discount rate, and approximately $1.14 million to $6.42 million at a 7 percent discount rate. Our primary annualized estimates are approximately $2.66 million at a 3 percent discount rate and $2.71 million at a 7 percent discount rate. The primary estimates of the present value of total cost savings in the 10 years following any final rule that may be issued based on this proposed rule are $24.55 million at a 3 percent rate of discount and $19.02 million at a 7 percent rate of discount. If the proposed rule is finalized, society may experience welfare gains from reductions in AMR due to the rule. These welfare gains would be in the form of decreased mortality, morbidity, and medical costs. Unfortunately, the magnitude of these potential benefits is difficult to forecast, and we do not quantify these impacts in the analysis. 

The costs of the proposed rule, if finalized, are associated with costs to industry for reading and understanding the rule, preparing and submitting PMAs, and other costs related to the PMA process and maintaining the class III designation. FDA also incurs costs from reviewing PMAs, annual and supplemental reports, and inspection activities. When annualized over a period of 10 years, we estimate these costs range from approximately $0.72 million to $1.25 million at a 3 percent discount rate, and approximately $0.65 million to $1.17 million at a 7 percent discount rate. Our primary annualized estimates are approximately $0.92 million at a 3 percent discount rate and $0.85 million at a 7 percent discount rate. The primary estimates of the present value of total costs in the 10 years following any final rule that may be issued based on the proposed rule are approximately $7.23 million at a 3 percent discount rate and $6.48 million at a 7 percent discount rate.

Regulatory Impact Analysis

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) (PDF 382 KB)

Federal Register: 88 FR 83774
Publication Date: 11/30/2023 
Docket: FDA–2023–N–3392