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 cervix 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 Condom. 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 semen to aid in the (5) Safety and effectiveness data diagnosis of infertility. must demonstrate that the device pre- (b) Classification. (1) Class II (special vents hemorrhoids in women under- controls) for condoms made of mate- going spontaneous vaginal delivery, in rials other than natural rubber 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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