Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
Information
Type
Rule
Regulated products
Published
September 27, 2018
Last updated
September 27, 2018
Description
Document number 2018-21044. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to "single-use internal condom," a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for "female condom," a preamendments class III device (product code OBY), by renaming the device "multiple-use female condom," to distinguish it from the "single-use internal condom." This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)