Good news for sexual health advocates: in a final order issued today, the U.S. Food and Drug Administration (FDA) changed the classification of female condoms from a class III device to a lower-risk class II device—the same classification shared by male condoms. The change will make it easier for manufacturers to bring the product to market, as the regulatory requirements for a class II device are lower than for the class III.
The order also includes a new name for the product. The “single-use female condom” will now be called the “single-use internal condom,” reflecting its potential use during anal sex—a new indication for the product. Currently, only one female condom—the FC2 Female Condom—is available in the U.S., and it is sold by prescription. For those without insurance, it is also available for purchase online through the manufacturer, and may be available for patients at health departments or clinics. This new FDA ruling classifies the single-use internal condom as an over-the-counter (OTC) device, opening the door for greater access.
“The device is assigned the generic name single-use internal condom, and it is identified as an OTC sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes.”
The reclassification comes after years of advocacy efforts seeking the change to help improve access. This is reflected in the public comments to the FDA in support of the change. As the FDA order notes, the “overwhelming majority of commenters supported the proposed reclassification, name change, and the general effort to increase patient access to single-use internal condoms.”