CDRH Updates: Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document

The Food and Drug Administration (FDA) has developed this guidance as a special controls guidance for male condoms made from natural rubber latex without spermicidal lubricant (latex condoms).1 This guidance is issued in conjunction with a Federal Register notice announcing the amendment of 21 CFR 884.5300, an existing classification for condoms, from class II (performance standards) to class II (special controls). The amended classification designates this guidance document as the special control for latex condoms.