Guidance on Labeling for Natural Rubber Latex Condoms

This ICR pertains to information that manufactures and repackagers of natural rubber latex condoms disclose to the health professionals who use or prescribe the device or the lay consumers who use the device. Natural rubber latex condoms without spermicidal lubricant are class II devices; devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance. The Food and Drug Administration (FDA) describes in a special controls guidance document its labeling recommendations for condoms without spermicidal lubricant. Respondents are expected to comply with the requirement of special controls and address the issues of safety and effectiveness identified in the special controls guidance, either by following the recommendations in the guidance or by some other means that provides equivalent assurance of safety and effectiveness.7

The latest form for Guidance on Labeling for Natural Rubber Latex Condoms expires 2021-05-31 and can be found here.