support a patient during diagnostic examinations or surgical procedures.

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

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994]

§878.4960 Operating tables and accessories and operating chairs and accessories.

(a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or airpowered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

(b) Classification. Class I.

[55 FR 48440, Nov. 20, 1990]

§878.5000 Nonabsorbable

poly(ethylene terephthalate) gical suture.

(a)

sur

Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. (b) Classification. Class II.

[56 FR 24685, May 31, 1991]

(a) Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

(b) Classification. Class II.

[56 FR 24685, May 31, 1991]

§ 878.5030 Natural nonabsorbable silk surgical suture.

non

(a) Identification. Natural nonabsorbable silk surgical suture is a absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

(b) Classification. Class II (special controls).

[58 FR 57558, Oct. 26, 1993]

Subpart F-Therapeutic Devices

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a) Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient. (b) Classification. Class II.

§ 878.5350 Needle-type epilator.

(a) Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine neeIdle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.

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

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]

been established of the requirement for premarket approval. See §878.3.

§ 878.5900 Nonpneumatic tourniquet.

(a) Identification. A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

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

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994]

§878.5910 Pneumatic tourniquet.

(a) Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

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

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]

880.2740 Surgical sponge scale.

880.2800 Sterilization process indicator. 880.2900 Clinical color change thermometer. 880.2910 Clinical electronic thermometer. 880.2920 Clinical mercury thermometer.

Subparts D-E-(Reserved)

Subpart F-General Hospital and Personal Use Therapeutic Devices

880.5025 I.V. container.

880.5045 Medical recirculating air cleaner. 880.5075 Elastic bandage.

880.5090 Liquid bandage.

880.5100 AC-powered adjustable hospital bed. 880.5110 Hydraulic adjustable hospital bed. 880.5120 Manual adjustable hospital bed. 880.5130 Infant radiant warmer. 880.5140 Pediatric hospital bed.

880.5150 Nonpowered flotation therapy mattress.

880.5160 Therapeutic medical binder. 880.5180 Burn sheet.

880.5200 Intravascular catheter.

880.5210 Intravascular catheter securement device.

880.5240 Medical adhesive tape and adhesive bandage.

880.5270 Neonatal eye pad.

880.5300 Medical absorbent fiber.

880.5400 Neonatal incubator.

880.5410 Neonatal transport incubator.

880.5420 Pressure infusor for an I.V. bag. 880.5430 Nonelectrically powered fluid injec

tor.

880.6880

Steam sterilizer.

880.6900

Hand-carried stretcher.

880.5500 AC-powered patient lift.

880.5510 Non-AC-powered patient lift.

880.5550 Alternating pressure air flotation

mattress.

880.5560 Temperature regulated water mattress.

880.5570 Hypodermic single lumen needle. 880.5630 Nipple shield.

880.5640 Lamb feeding nipple.

880.5680 Pediatric position holder.

880.5700 Neonatal phototherapy unit.

880.5725 Infusion pump.

880.5740 Suction snakebite kit.

880.5760 Chemical cold pack snakebite kit. 880.5780 Medical support stocking. 880.5820 Therapeutic scrotal support. 880.5860 Piston syringe.

880.5950 Umbilical occlusion device.

Subpart G-General Hospital and Personal Use Miscellaneous Devices

880.6025 Absorbent tipped applicator. 880.6050 Ice bag.

880.6060 Medical disposable bedding. 880.6070 Bed board.

880.6910 Wheeled stretcher.

880.6920 Syringe needle introducer.

880.6960 Irrigating syringe.

880.6970 Liquid crystal vein locator.

880.6980 Vein stabilizer.

AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).

SOURCE: 45 FR 69682-69737, Oct. 21, 1980, unless otherwise noted.

Subpart A-General Provisions § 880.1 Scope.

(a) This part sets forth the classification of general hospital and personal use 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 general hospital and personal use 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 17738, May 11, 1987]

§ 880.3 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" devices 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 17738, May 11, 1987]

§ 880.9 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

Subpart C-General Hospital and Personal Use Monitoring Devices §880.2200 Liquid crystal forehead temperature strip.

(a) Identification. A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.

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

§880.2400 Bed-patient monitor.

(a) Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

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

[45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994]

§ 880.2420 Electronic monitor for gravity flow infusion systems.

(a) Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.

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

§ 880.2460 Electrically powered spinal fluid pressure monitor.

(a) Identification. An electrically powered spinal fluid pressure monitor is an electrically powered device used to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. The device includes signal amplification, conditioning, and display equipment.

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

§ 880.2500 Spinal fluid manometer.

(a) Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid. (b) Classification. Class II (performance standards).

§ 880.2700 Stand-on patient scale.

(a) Identification. A stand-on patient scale is a device intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.

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

§ 880.2720 Patient scale.

(a) Identification. A patient scale is a device intended for medical purposes