FDA Final Order Renames Single-Use Female Condom

PUBLISHED: Sep 26, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Rural Health Clinics

The U.S. Food and Drug Administration (FDA) published the final order, "Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom." Effective October 29, 2018. This final order reclassifies the device currently known as the “single-use female condom” from class III to class II, and renames the device as the “single-use internal condom.”

The decision to reclassify and rename the device was based on the FDA’s evaluation of new information that was not available at the time of the original single-use female condom’s premarket approval, as well as public comments received in response to FDA’s proposal to reclassify these devices as outlined in the proposed order published on December 4, 2017.

With implementation of this order, the FDA:

  • Identifies the special controls necessary to provide a reasonable assurance of safety and effectiveness of the single-use internal condom, which supported the decision to reclassify from class III to class II.
  • Renames the current regulation for the class III “female condom” to the “multiple-use female condom” to differentiate it from the single-use internal condom.
  • Identifies the new classification regulation to include use of these devices for vaginal or anal intercourse.

The FDA is committed to ensuring the safety and effectiveness of devices important to sexual and reproductive health. With this in mind, the final order highlights that when used correctly, the single-use internal condom is the only female-controlled method that is intended to prevent both pregnancy and the transmission of sexually transmitted infections (STIs). The single-use internal condom can also be used during anal intercourse to protect against STIs.

Follow the link below for additional information.

Want to read the full alert and receive alert emails?

Browse Additional Alerts