A new female condom, made out of a new synthetic rubber called nitrile by Female Health Co. out of Chicago, Illinois, is about to receive a judgment from an FDA advisory panel, potentially clearing it for approval.
Reuters reports:
The FC2 Female Condom, made by Female Health Co, is made with a synthetic rubber using a process similar to male condoms that the company says is less labor intensive and should reduce its current cost…
But FDA regulatory staff questioned whether the company should have conducted specific trials to show how well the FC2 prevents women from contracting diseases or becoming pregnant.
Female Health said it did not conduct such studies because FC2 uses a new material but is otherwise similar to the version already on the U.S. market, the FDA staff said in documents released on Tuesday ahead of the panel meeting.
More from Reuters…
FC2 product page…
Product brochure (.pdf)…