Wound wash saline comment
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposal to declare wound wash saline products unapproved new drugs is misguided, given the agency's history of regulating wound cleansers as medical devices, the Washington office of King & Spalding says in a Sept. 16 letter to FDA. In a June 19 Federal Register notice, the agency includes wound wash saline in a list of drug ingredients and products proposed to not be generally recognized as safe and effective and to require an approved new drug application for future marketing (1"The Tan Sheet" June 23, 2008, p. 7). Since the Center for Devices and Radiological Health regards such sterile wash products as functioning through a physical mechanism rather than chemical or metabolic action, King & Spalding encourages FDA to clarify in a final rule "that not all 'wound wash saline' products are 'drugs,' much less 'new drugs.'
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FDA's proposal to declare wound wash saline products unapproved new drugs is misguided, given the agency's history of regulating wound cleansers as medical devices, the Washington office of King & Spalding says in a Sept. 16 letter to FDA. In a June 19 Federal Register notice, the agency includes wound wash saline in a list of drug ingredients and products proposed to not be generally recognized as safe and effective and to require an approved new drug application for future marketing (1 (Also see "FDA Proposes Aloe Vera, Other Ingredients For Non-GRASE List" - Pink Sheet, 23 Jun, 2008.), p. 7). Since the Center for Devices and Radiological Health regards such sterile wash products as functioning through a physical mechanism rather than chemical or metabolic action, King & Spalding encourages FDA to clarify in a final rule "that not all 'wound wash saline' products are 'drugs,' much less 'new drugs.'" |