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# FDA Reclassifies/Renames Female Condom
- URL: https://www.fdaweb.com/fda-reclassifies-renames-female-condom/
- Published: 2017-12-04T12:00:00.000Z
- Updated: 2026-09-14T23:04:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140252

*Federal Register* notice: FDA has proposed to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device (product code MBU), into Class 2 (special controls) subject to 510(k) clearance. FDA is also identifying the proposed special controls that it believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-12-04/pdf/2017-26011.pdf?ref=fdaweb.com).