Female condom approved
This article was originally published in The Gray Sheet
Executive Summary
The Female Health Company is building manufacturing capacity for its second generation FC2 female condom after receiving PMA approval March 11. The device is cleared to prevent pregnancy, HIV/AIDS and other sexually transmitted infections, and is expected to cost up to 30% less than the firm's original FC female condom. The company hopes that the lower price will boost sales to HIV prevention programs in the U.S. and globally. While the device is currently available overseas and FHC has the capacity to make 30 million units annually, it is aiming to boost production to 75-80 million units a year, the company states. FC2 approval was recommended by FDA's Obstetrics and Gynecology Devices Panel Dec. 11 (1"The Gray Sheet" Dec. 15, 2008, p. 14)