Posted in Regulatory and Compliance by MDDI Staff on November 15, 2016
On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely used to treat medical conditions ranging from minor cuts and burns, to diabetic foot ulcers and historically have been cleared by FDA through the 510(k) process. While this is not the first time FDA has looked to experts to help evaluate the classification of wound dressings containing drugs, this panel meeting was prompted in part by evolutions in technology, the breadth of cleared indications for use, the extensive list of ingredients (many with known or potential chemical activity), and the public health implications associated with antimicrobial resistance (as evidenced by FDA’s recent ban of 19 antibacterial agents in soaps).
The panel’s main focus was on dressings containing antimicrobial drugs, but certain single entity dressings containing materials that are not antimicrobial drugs or preservatives, but that act solely within the dressing to enhance its barrier properties, were also discussed. The panel discussion was largely consistent with FDA’s historical regulatory approach for devices containing drugs, but also highlighted that these products present unique regulatory challenges and public health concerns.
A critical point of discussion involved the differentiation of these products based on the purpose of the drug and how such differences could lead to different regulatory pathways. The use of antimicrobial agents that could lead to increased antimicrobial resistance or toxicity also was a focal point of the discussion and was of particular interest to the panel members. The panel believed that increased scrutiny and regulation may be necessary for some of these products to prevent or limit future increases in antimicrobial resistance.
FDA’s Regulatory Framework and Antimicrobial Resistance Concerns
Antimicrobial agents, which are commonly used to treat, manage, and prevent infectious diseases, come in many forms, all of which are expected to kill or inhibit the growth of microorganisms including bacteria, viruses, fungi, and parasites. Antimicrobials have been added to a variety of medical devices to reduce the risk of infections, including through the prevention of microbial growth on the device itself.
FDA frequently views the addition of an antimicrobial agent to increase the risks associated with a medical device. Many Class I, 510(k)-exempt devices, including hydrogel wound dressings and mattress covers for medical purposes, for example, require 510(k) clearance when an antimicrobial agent is added. FDA generally considers the addition of these agents to change the fundamental scientific technology of the device, thus exceeding the limitations of their 510(k) exemptions.