FDA Combination Product Classification Again Struck Down By D.C. Court

Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications. Manufacturers of devices face less burdensome regulation and far cheaper application fees. A long-litigated case, Prevor v. FDA (Prevor II), highlights the gravity of FDA’s decision with regards to combination products. After five years in court, Prevor and the FDA continue to dispute whether Prevor’s Diphoterine Skin Wash (DSW) should be regulated as a medical device—Prevor’s preference—or a drug. Most recently, FDA argued that DSW meets the drug definition because chemical action "meaningfully contributes" to DSW's intended purpose. The court struck down this argument, marking a win for industry, but refused to go all the way towards considering DSW a device. DSW was developed to prevent and minimize chemical burn injuries that occur in industrial workplaces due to accidental exposure to chemicals. Specifically, the product is used by “spraying the pressurized contents of the canister on to the skin to physically and mechanically remove splashes of acids and bases off the skin by washing them away.” In August 2009, Prevor submitted a Request for Designation (RFD) to FDA's Office of Combination Products (OCP) recommending that DSW be classified as a device, regulated by the Center for Devices and Radiological Health. OCP instead classified DSW as a combination product, and, finding that the liquid substance inside the canister “ac...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs