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# FDA Reclassifies Single-use Female Condoms
- URL: https://www.fdaweb.com/fda-reclassifies-single-use-female-condoms/
- Published: 2018-09-28T12:00:00.000Z
- Updated: 2026-09-15T00:34:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142471

*Federal Register* notice: FDA has issued a final order to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device (regulated under product code MBU), into Class 2 (special controls) subject to premarket notification (510(k)). FDA is also amending the existing device identification for “female condom,” a preamendments Class 3 device (product code OBY), by renaming the device “multiple-use female condom,’” to distinguish it from the single-use internal condom. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21044.pdf?ref=fdaweb.com).