FDA Proposes Female Condom Rule Change

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The U.S. Food and Drug Administration has released a proposed order to reclassify and rename the single-use female condom.  Reclassification from a Class III to a Class II medical device gives manufacturers of these condoms a simpler regulatory pathway to marketing their products in the U.S.  Degendering the product type, i.e., renaming it as a “single-use internal condom,” allows for expansion of its indications for use, affirming its use by diverse populations with diverse needs.  Those wishing to submit comments about the proposed order must do so by February 2, 2018.

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Categorised in: Contraceptive, Methods, Regulatory

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