§ 884.5305 External condom for anal intercourse or vaginal intercourse.

(a) Identification. An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance data must demonstrate the total rate of clinical failure and rate of individual failure modes of the device based on an acute failure modes study. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The data must include an assessment of mechanical and material integrity, including an evaluation of device failure modes. For devices made of materials other than natural rubber latex, viral penetration testing must be conducted to evaluate barrier effectiveness to sexually transmitted infections. (3) The device must be demonstrated to be biocompatible. (4) Performance data must support the shelf life of the device by demonstrating device functionality and package integrity over the identified shelf life. (5) Labeling must include: (i) If indicated for vaginal intercourse, a contraceptive effectiveness table comparing typical use and perfect use pregnancy rates with the device to other available methods of birth control; (ii) Statement regarding compatibility with additional lubricant types; (iii) Statement regarding the adverse events associated with the device, including transmission of infection, pregnancy, adverse tissue reaction, mechanical injury, or improper device use; (iv) Expiration date; and (v) The following information, warnings and precautions: (A) The sexually transmitted infections (STIs) for which the device is most protective, the degree of protection the device provides against specific types of STIs, and the STIs the device does not protect against; (B) A statement that the device does not completely eliminate the risks of pregnancy and sexually transmitted infections and that risk can be decreased with correct and consistent use; (C) A warning regarding the risk of device failure during anal intercourse if adequate lubricant is not used; (D) A warning stating that the device cannot be used multiple times and is limited to one sex act; and (E) A precaution stating not to use the device if the user is at risk for material related allergic reactions.