Will a New Female Condom Catch On?
The New York Times has a piece today on a new design for the female condom, which is supposed to transmit more warmth and move “more like a vagina” than the old design.
According to the piece, however, female condoms must pass through a more rigorous process than male condoms to gain FDA approval:
While the F.D.A. designates male condoms as Class 2 medical devices — meaning that a new maker has to pass tests only for leakage and bursting — it puts female condoms in Class 3, the same category as pacemakers, heart valves and silicone breast implants…the Class 3 listing means that any new design must pass clinical trials, which would cost $3 million to $6 million. “That’s a huge, huge impediment, close to a 100 percent block, because no one’s willing to put up that sort of money,” Dr. Free said.