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Case Detail


In re: Emergency Eyewash Products
On March 7, 2014, WLF filed formal comments with FDA, urging it to reconsider the manner in which it regulates emergency eyewash (EE) products. The primary intended purpose of most EE products is to flush or irrigate the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. FDA has routinely classified EE products as “drugs,” not “devices,” a classification that makes it more difficult for a manufacturer to gain FDA marketing approval. WLF noted that the classification of a medical product focuses on how the product achieves its “primary intended purposes.” If those purposes are achieved by “chemical action in or on the body of man,” then the product is classified as a drug; if not, then the product is a device. WLF argued that most EE products should be classified as devices because they achieve their primary intended purpose (flushing or irrigating the eye to rid it of contaminants) through a physical action, not a chemical action.
Case Status:
Awaiting FDA response.
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