Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom. Final order
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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 (s... ...