Zdrowie i gospodarka · 14/11/2005

FDA Releases Draft Guidance for Labeling of Natural Rubber Latex Condoms

The US Food and Drug Administration (FDA) has made available a draft guidance document outlining the labeling requirements for male condoms made of natural rubber latex, which may contain spermicidal lubricant containing nonoxynol-9 (N-9). The draft guidance aims to help these condoms comply with special controls for class II devices, as proposed in a separate rule published in the Federal Register.