Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
Information
Type
Proposed Rule
Regulated products
Published
December 4, 2017
Last updated
December 4, 2017
Description
Document number 2017-26011. The Food and Drug Administration (FDA) is proposing to reclassify single-use female condoms, renaming the device to "single- use internal condom," a postamendments class III device (product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing to amend 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." If finalized, this order will reclassify single-use female condoms from class III to class II and reduce regulatory burdens on industry as 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)