completed PDP in effect before being placed in commercial distribution.

[44 FR 51730-51778, Sept. 4. 1979, as amended at 53 FR 48621, Dec. 1, 1988]

$ 882.5850 Implanted spinal cord stimulator for bladder evacuation.

(a) Identification. An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

(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 is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any implanted spinal cord stimulator for bladder evacuation that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an implanted spinal cord stimulator for bladder evacuation that was in commercial distribution before May 28, 1976. Any other implanted spinal cord stimulator for bladder evacuation shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996]

tient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe.

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987]

§ 882.5870 Implanted peripheral nerve stimulator for pain relief.

(a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

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

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief. (a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

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

§ 882.5900 Preformed craniosynostosis strip. (a)

Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.

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

§ 882.5910 Dura substitute.

(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

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

§ 882.5940 Electroconvulsive

device.

(a)

therapy

Identification. An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression) by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987]

§ 882.5950 Artificial embolization device.

(a) Identification. An artificial embolization device is an object that is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation.

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987]

§ 882.5960 Skull tongs for traction.

(a) Identification. Skull tongs for traction is an instrument used to im

mobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

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

§ 882.5970 Cranial orthosis.

(a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

(b) Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)). [63 FR 40651, July 30, 1998]

884.2640 Fetal phonocardiographic monitor and accessories.

884.5310 Condom with spermicidal lubricant. 884.5320 Glans sheath.

884.5350 Contraceptive diaphragm and accessories.

884.5360 Contraceptive intrauterine device (IUD) and introducer.

884.5380 Contraceptive tubal occlusion device (TOD) and introducer. 884.5390 Perineal heater. 884.5400 Menstrual cup. 884.5425

Scented or scented deodorized menstrual pad.

884.5435 Unscented menstrual pad.

884.5460 Scented or scented deodorized menstrual tampon.

884.5470 Unscented menstrual tampon. 884.5900 Therapeutic vaginal douche apparatus.

884.5920 Vaginal insufflator. 884.5940 Powered vaginal muscle stimulator for therapeutic use.

884.5960 Genital vibrator for therapeutic

Subpart A-General Provisions §884.1 Scope.

(a) This part sets forth the classification of obstetrical and gynecological devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, a obstetrical and gynecological device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

[52 FR 17740, May 11, 1987]

§ 884.3 Effective dates of_requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided

in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

[52 FR 17740, May 11, 1987]

§ 884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based

upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

time of ovulation and the penetrability of cervical mucus to motile sperm. (b) Classification. Class I (general controls).

[47 FR 14706, Apr. 6, 1982]

§ 884.1050 Endocervical aspirator.

(a) Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

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

§ 884.1060 Endometrial aspirator.

(a) Identification. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 884.3.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987]

brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).

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

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 884.3.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987]

§ 884.1175 Endometrial suction curette and accessories.

(a) Identification. An endometrial suction curette is a device used to remove material from the uterus and from the