concerning records, and § 820.198, with respect to complaint files.

[51 FR 40388, Nov. 6, 1986]

§ 868.5800 Tracheostomy tube and tube cuff.

(a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

(b) Classification. Class II.

[51 FR 40389, Nov. 6, 1986]

§ 868.5810 Airway connector.

(a) Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

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

§ 868.5820 Dental protector.

(a) Identification. A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity. (b) Classification. Class II (performance standards).

§ 868.5830 Autotransfusion apparatus.

(a) Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

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

§ 868.5860 Pressure tubing and accessories.

(a) Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

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

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

§ 868.5935 External negative pressure ventilator.

(a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

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

§ 868.5955 Intermittent mandatory ventilation attachment.

(a) Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

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

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a) Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

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

§ 868.5975 Ventilator tubing.

(a) Identification. Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

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

§ 868.5995 Tee drain (water trap).

(a) Identification. A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.

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

Subpart G-Miscellaneous

§ 868.6100 Anesthetic cabinet, table, or tray.

(a) Identification. An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter.

[42 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989]

§ 868.6175 Cardiopulmonary cart.

emergency

The

(a) Identification. A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation. (b) Classification. Class I. device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations in Part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[42 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989]

§ 868.6225 Nose clip.

(a) Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations in Part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[42 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989]

(c) To avoid duplicative listings, a cardiovascular 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 17735, May 11, 1987]

§ 870.3 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 approv