Female Condom Gets Rebrand to Spur New Manufacturers (XBIZ)

Read the full article by Rhett Pardon at XBIZ.com 

WASHINGTON — The FDA hopes that regulatory reclassification of condoms designed for vaginal use will encourage potential new manufacturers to enter the market and provide greater access.

Once called the “female condom,” the federally rebranded “internal condom” can go inside the vagina or the anus to prevent STIs and pregnancy.

The female condom debuted in 1993 as a first-of-its-kind device that allowed receptive partners to control the use of a condom and wear it themselves as protection from STIs and unwanted pregnancies. Its successor, the FC2 female condom, was released in 2009.

To date, there had been only one maker of internal condoms, Veru’s FC2 Female Condom, which could only be obtained through prescription or purchased directly from the company, nonprofit health centers or other government health agencies.

For years, health advocates had campaigned over the stringent regulations on internal condoms that made them excessively difficult to come by.

Now, female condoms have been reclassified into the same category as male condoms.

In late September, the FDA released in the Federal Register three significant changes about female condoms.