Food and Drug Administration, HHS § 884.5310

§ 884.5200 Hemorrhoid prevention ber shall have an approved PMA or a pressure wedge. declared completed PDP in effect be- (a) Identification. A hemorrhoid pre- fore being placed in commercial dis- vention pressure wedge provides me- tribution. chanical support to the perianal region [45 FR 12684–12720, Feb. 26, 1980, as amended during the labor and delivery process. at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. External mechanical support of the 27, 1996] perianal region is intended to help pre- vent the occurrence of external hemor- § 884.5250 Cervical cap. rhoids associated with vaginal child- (a) Identification. A cervical cap is a birth. flexible cuplike receptacle that fits (b) Classification. Class II (special over the to collect menstrual controls). The special controls for this flow or to aid artificial insemination. device are: This generic type of device is not for (1) The sale, distribution, and use of contraceptive use. this device are restricted to prescrip- (b) Classification. Class II (perform- tion use in accordance with § 801.109 of ance standards). this chapter. (2) The labeling must include specific § 884.5300 . instructions regarding the proper (a) Identification. A condom is a placement and use of the device. sheath which completely covers the (3) The device must be demonstrated penis with a closely fitting membrane. to be biocompatible. The condom is used for contraceptive (4) Mechanical bench testing of mate- and for prophylactic purposes (pre- rial strength must demonstrate that venting transmission of sexually trans- the device will withstand forces en- mitted infections). The device may also countered during use. be used to collect to aid in the (5) Safety and effectiveness data diagnosis of . must demonstrate that the device pre- (b) Classification. (1) Class II (special vents hemorrhoids in women under- controls) for made of mate- going spontaneous vaginal delivery, in rials other than latex, addition to general controls. including natural membrane (skin) or synthetic. [76 FR 21238, Apr. 15, 2011] (2) Class II (special controls) for nat- ural rubber latex condoms. The guid- § 884.5225 Abdominal decompression ance document entitled ‘‘Class II Spe- chamber. cial Controls Guidance Document: La- (a) Identification. An abdominal de- beling for Natural Rubber Latex compression chamber is a hoodlike de- Condoms Classified Under 21 CFR vice used to reduce pressure on the 884.5300’’ will serve as the special con- pregnant patient’s abdomen for the re- trol. See § 884.1(e) for the availability of lief of abdominal pain during preg- this guidance document. nancy or labor. (b) Classification. Class III (premarket [73 FR 66538, Nov. 10, 2008] approval). § 884.5310 Condom with spermicidal (c) Date PMA or notice of completion of lubricant. a PDP is required. A PMA or a notice of completion of a PDP is required to be (a) Identification. A condom with filed with the Food and Drug Adminis- spermicidal lubricant is a sheath which tration on or before December 26, 1996 completely covers the penis with a for any abdominal decompression closely fitting membrane with a lubri- chamber that was in commercial dis- cant that contains a spermicidal agent, tribution before May 28, 1976, or that nonoxynol–9. This condom is used for has, on or before December 26, 1996 contraceptive and prophylactic pur- been found to be substantially equiva- poses (preventing transmission of vene- lent to an abdominal decompression real disease). chamber that was in commercial dis- (b) Classification. Class II (perform- tribution before May 28, 1976. Any ance standards). other abdominal decompression cham- [47 FR 49022, Oct. 29, 1982]

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