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Subpart F-Obstetrical and Gyne for use with an anesthetic drug. This cological Therapeutic De

device is used to administer regional vices

blocks (e.g., paracervical, uterosacral,

and pudendal) that may be used during $ 884.5050 Metreurynter-balloon abor

labor, delivery, or both. tion system.

(b) Classification. Class II (perform(a) Identification. A metreurynter-bal

ance standards). loon abortion system is a device used

$ 884.5150 Nonpowered breast pump. to induce abortion. The device is inserted into the uterine cavity, inflated. (a) Identification. A nonpowered and slowly extracted. The extraction of breast pump is a manual suction device the balloon from the uterus causes di

used to express milk from the breast. lation of the cervical os. This generic (b) Classification. Class I. The device type of device may include pressure is exempt from the premarket notificasources and pressure controls.

tion procedures in subpart E of part 807 (b) Classification. Class III (premarket of this chapter, subject to the limit approval).

tions in $ 884.9, if the device is using ei(c) Date PMA or notice of completion of ther a bulb or telescoping mechanism a PDP is required. A PMA or a notice of which does not develop more than 250 completion of a PDP is required to be mm Hg suction, and the device matefiled with the Food and Drug Adminis- rials that contact breast or breast milk tration on or before December 26, 1996 do not produce cytotoxicity, irritation, for any metreurynter-balloon abortion or sensitization effects. system that was in commercial dis

[45 FR 12684-12720, Feb. 26, 1980, as amended tribution before May 28, 1976, or that

at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July has, on or before December 26, 1996 25, 2001) been found to be substantially equivalent to a metreurynter-balloon abor- $ 884.5160 Powered breast pump. tion system that was in commercial (a) Identification. A powered breast distribution before May 28, 1976. Any

pump in an electrically powered sucother metreurynter-balloon abortion

tion device used to express milk from system shall have an approved PMA or

the breast. a declared completed PDP in effect be

(b) Classification. Class II (performfore being placed in commercial dis

ance standards). tribution. [45 FR 12684-12720, Feb. 26, 1980, as amended

$ 884.5225 Abdominal decompression at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept.

chamber. 27, 1996)

(a) Identification. An abdominal de$ 884.5070 Vacuum abortion system.

compression chamber is a hoodlike de

vice used to reduce pressure on the (a) Identification. A vacuum abortion pregnant patient's abdomen for the resystem is a device designed to aspirate lief of abdominal pain during preg. transcervically the products of concep- nancy or labor. tion or menstruation from the uterus (b) Classification. Class III (premarket by using a cannula connected to a suc- approval). tion source. This device is used for

(c) Date PMA or notice of completion of pregnancy termination or menstrual a PDP is required. A PMA or a notice of regulation. This type of device may in- completion of a PDP is required to be clude aspiration cannula, vacuum filed with the Food and Drug Adminissource, and vacuum controller.

tration on or before December 26, 1996 (b) Classification. Class II (perform for any abdominal decompression ance standards).

chamber that was in commercial dis

tribution before May 28, 1976, or that $ 884.5100 Obstetric anesthesia set.

has, on or before December 26, 1996 (a) Identification. An obstetric anes- been found to be substantially equivathesia set is an assembly of antiseptic lent to an abdominal decompression solution, needles, needle guides, sy- chamber that was in commercial disringes, and other accessories, intended tribution before May 28, 1976. Any

other abdominal decompression chamber shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996)

$884.5250 Cervical cap.

(a) Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

(b) Classification. Class II (performance standards).

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 12, 2002, for any glans sheath that was in commercial distribution before May 28, 1976, or that has, on or before September 12, 2002, been found to be substantially equivalent to a glans sheath that was in commercial distribution before May 28, 1976. Any other glans sheath shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [59 FR 67187, Dec. 29, 1994, as amended at 67 FR 40849, June 14, 2002)

$ 884.5300 Condom.

(a) Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of venereal disease). The device may also be used to collect semen to aid in the diagnosis of infertility.

(b) Classification. Class II (performance standards).

8884.5310 Condom with spermicidal

lubricant. (a) Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

(b) Classification. Class II (performance standards). (47 FR 49022, Oct. 29, 1982]

$884.5330 Female condom.

(a) Identification. A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. No effective date has been established of the requirement for premarket approval for the devices described in paragraph (b) of this section. See $ 884.3 for effective dates of requirement for premarket approval. [65 FR 31455, May 18, 2000]

8884.5320 Glans sheath.

(a) Identification. A glans sheath device is a sheath which covers only the glans penis or part thereof and may also cover the area in the immediate proximity thereof, the corona and frenulum, but not the entire shaft of the penis. It is indicated only for the prevention of pregnancy and not for the prevention of sexually-transmitted diseases.

$ 884.5350 Contraceptive diaphragm

and accessories. (a) Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

(b) Classification. Class II (performance standards).

tion on or before December 30, 1987, for any TOD and introducer that was in commercial distribution before May 28, 1976, or that has on or before December 30, 1987, been found to be substantially equivalent to a TOD and introducer that was in commercial distribution before May 28, 1976. Any other TOD and introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 36883, Oct. 1, 1987)

$ 884.5360 Contraceptive intrauterine

device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is placed high in the uterine fundus with a string extending from the device through the cervical os into the vagina. This generic type of device includes the introducer, but does not include contraceptive IUD's that function by drug activity, which are subject to the new drug provisions of the Federal Food, Drug, and Cosmetic Act (see $310.502).

(b) Classification. Class III (premarket approval).

(c) Labeling. Labeling requirements for contraceptive IUD's are set forth in $ 801.427.

(d) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before August 4, 1986, for any IUD and introducer that was in com

cial distribution before May 28. 1976, or that has on or before August 4, 1986, been found to be substantially equivalent to an IUD and introducer that was in commercial distribution before May 28, 1976. Any other IUD and introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 12684-12720, Feb. 26. 1980, as amended at 51 FR 16649, May 5, 1986)

$884.5390 Perineal heater.

(a) Identification. A perineal heater is a device designed to apply heat directly by contact, or indirectly from a radiant source, to the surface of the perineum (the area between the vulva and the anus) and is used to soothe or to help heal the perineum after an episiotomy (incision of the vulvar orifice for obstetrical purposes).

(b) Classification. Class II (performance standards).

me

8884.5400 Menstrual cup.

(a) Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

(b) Classification. Class II (performance standards).

$ 884.5380 Contraceptive tubal occlu

sion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and intro ducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administra

$884.5425 Scented or scented deodor.

ized menstrual pad. (a) Identification. A scented or scented deodorized menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual pad) or for deodorizing purposes (scented deodorized menstrual pad). This generic type of device includes sterile scented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with added antimicrobial agents or other drugs.

(b) Classification. (1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of

part 807 of this chapter, subject to the (b) Classification. Class II (performlimitations in $884.9. This exemption ance standards). does not include the intralabial pads 145 FR 12684-12720, Feb. 26, 1980, as amended and reusable menstrual pads.

at 45 FR 51186, Aug. 1, 1980) (2) Class II (special controls) for scented or scented deodorized men 8 884.5470 Unscented menstrual tamstrual pads made of materials not de pon. scribed in paragraph (b)(1).

(a) Identification. An unscented men[45 FR 12684–12720, Feb. 26, 1980, as amended strual tampon is a device that is a plug at 45 FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. made of cellulosic or synthetic mate24, 1996; 66 FR 38809, July 25, 2001)

rial that is inserted into the vagina

and used to absorb menstrual or other $ 884.5435 Unscented menstrual pad.

vaginal discharge. This generic type of (a) Identification. An unscented men- device does not include menstrual tamstrual pad is a device that is a pad pons treated with scent (i.e., fragrance made of cellulosic or synthetic mate materials) or those with added antirial which is used to absorb menstrual microbial agents or other drugs. or other vaginal discharge. This ge- (b) Classification. Class II (performneric type of device includes sterile ance standards). unscented menstrual pads used for medically indicated conditions, but $884.5900 Therapeutic vaginal douche does not include menstrual pads treat

apparatus. ed with scent (i.e., fragrance materials) (a) Identification. A therapeutic vagor those with added antimicrobial inal douche apparatus is a device that agents or other drugs.

is a bag or bottle with tubing and a (b) Classification. Class I (general con nozzle. The apparatus does not include trols). The device is exempt from the douche solutions. The apparatus is inpremarket notification procedures in tended and labeled for use in the treatsubpart E of part 807 of this chapter ment of medical conditions except it is only when the device is made of com- not for contraceptive use. After filling mon cellulosic and synthetic material the therapeutic vaginal douche appawith an established safety profile. This ratus with a solution, the patient uses exemption does not include the inter the device to direct a stream of solulabial pads and reusable menstrual tion into the vaginal cavity. pads.

(b) Classification. (1) Class II (per

formance standards). [45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 65 FR 2320, Jan.

(2) Class I if the device is operated by 14, 2000)

gravity feed. Devices subject to this

paragraph (b)(2) are exempt from the $884.5460 Scented or scented deodor premarket notification procedures in ized menstrual tampon.

subpart E of part 807 of this chapter, (a) Identification. A scented or scent

subject to the limitations in 8 884.9. ed deodorized menstrual tampon is a

(45 FR 12684-12720, Feb. 26, 1980, as amended device that is a plug made of cellulosic

at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July or synthetic material that is inserted 25, 2001) into the vagina and used to absorb menstrual or other vaginal discharge. $884.5920 Vaginal insufflator. It has scent (i.e., fragrance materials) (a) Identification. A vaginal added for aesthetic purposes (scented insufflator is a device used to treat menstrual tampon) or for deodorizing

vaginitis by introducing medicated purposes (scented deodorized menstrual

powder from a hand-held bulb into the tampon). This generic type of device

vagina through an open speculum. does not include menstrual tampons

(b) Classification. Class I. The device treated with added antimicrobial

is exempt from the premarket notificaagents or other drugs.

tion procedures in subpart E of part 807

of this chapter, subject to the limitations in 8884.9.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001)

$884.5970 Clitoral engorgement de

vice. (a) Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.

(b) Classification. Class II (special controls). The special control is a guidance document entitled: "Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices." [65 FR 47306, Aug. 2, 2000)

Subpart G-Assisted Reproduction

Devices

SOURCE: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.

$ 884.5940 Powered vaginal muscle

stimulator for therapeutic use. (a) Identification. A powered vaginal

vaginal muscle stimulator is an electrically powered device designed to stimulate directly the muscles of the vagina with pulsating electrical current. This device is intended and labeled for therapeutic use in increasing muscular tone and strength in the treatment of sexual dysfunction. This generic type of device does not include devices used to treat urinary incontinence.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 12, 2000, for any powered vaginal muscle stimulator for therapeutic use that was in commercial distribution before May 28, 1976, or that has, on or before July 12, 2000, been found to be substantially equivalent to a powered vaginal muscle stimulator that was in commercial distribution before May 28, 1976. Any other powered vaginal muscle stimulator for therapeutic use shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 19834, Apr. 13, 2000)

8884.6100 Assisted reproduction nee

dles. (a) Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

(b) Classification. Class II (special controls) (mouse embryo assay in mation, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

8 884.5960 Genital vibrator for thera

peutic use. (a) Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).

(b) Classification. Class II (performance standards).

8884.6110 Assisted reproduction cath

eters. (a) Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes. zygote(s). preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization

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