09/27/2018
After years of hard work and meetings, the FDA has moved to reclassify female condoms. They will be renamed single use internal condoms. Additionally this move, "reduces regulatory burden because these types of devices will no longer be required to submit" a more costly and extensive application for approval. This move also means they will no longer be classified as class iii medical devices and will now be classified as class ii and are classified as over the counter devices. I couldn't be more proud of the women and men who I had the pleasure of working with to push for these changes. I am extremely hopeful of what this might mean for the next generation.
AND YES WE STILL HAVE THEM IN STOCK IF YOU NEED THEM!!!!