Request for Comment by February 2, 2018: FDA proposes to reclassify single-use female condom, to be renamed single-use internal condom
FDA is proposing to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a post-amendments class III device (product code MBU), into class II (special controls) subject to pre-market 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 pre-amendments 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 pre-market approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.
You may read the entire Federal Register Notice and also make comments electronicallybefore February 2, 2018.
FDA is proposing to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a post-amendments class III device (product code MBU), into class II (special controls) subject to pre-market 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 pre-amendments 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 pre-market approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.
You may read the entire Federal Register Notice and also make comments electronicallybefore February 2, 2018.
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Food and Drug Administration
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