FDA Issues Proposed Order to Reclassify and Rename Single-Use Female Condom

Today, the U.S. Food and Drug Administration issued the proposed order, "Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom." The order proposes to reclassify the device currently known as the “single-use female condom” from class III to class II, and rename the device as the “single-use internal condom,” based on new information evaluated by the Agency. When used by women, the single-use internal condom is the only female-controlled method that provides both contraception and protection against sexually transmitted infections. The order also proposes to change the existing device identification for the class III “female condom” to the “multiple-use female condom.”

With this order, FDA also proposes to:

• identify the special controls believed necessary to provide a reasonable assurance of safety and effectiveness of the single-use internal condom, which supports reclassification from class III to class II;
• rename the current class III “female condom” to the “multiple-use female condom” to differentiate it from the single-use internal condom; and
• indicate that the new classification regulation includes the use of these devices for vaginal and/or anal intercourse.

If this proposed order is finalized, it is expected to reduce the regulatory burden on industry, as single-use internal condoms will no longer require premarket approval (PMA). Instead, these devices would require a less burdensome premarket notification (510(k)), prior to marketing.

We welcome your comments regarding this proposed order. The comment period closes in 60 days.

If you have any questions regarding this proposed order, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health