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PART 880–GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart A-General Provisions

hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to $878.9.

Sec. 880.1 Scope. 880.3 Effective dates of requirement for pre

market approval. 880.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

[63 FR 57060, Oct. 26, 1998]

Subpart B [Reserved]

$ 878.5650 Topical oxygen chamber for

extremities. (a) Identification. A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.

(b) Classification. Class III.

(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 8878.3. $878.5900 Nonpneumatic tourniquet.

(a) Identification. Anonpneumatic 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.

Subpart C-General Hospital and Personal

Use Monitoring Devices 880.2200 Liquid crystal forehead tempera

ture strip. 880.2400 Bed-patient monitor. 880.2420 Electronic monitor for gravity flow

infusion systems. 880.2460 Electrically powered spinal fluid

pressure monitor. 880.2500 Spinal fluid manometer. 880.2700 Stand-on patient scale. 880.2720 Patient scale. 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. 880.2930 Apgar timer.

Subparts D-E [Reserved) Subpart F-General Hospital and Personal

Use Therapeutic Devices

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

8878.5910 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)

880.5025 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 mat-

tress.
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. 880.5440 Intravascular administration set.

194-069 D-01--13

880.5450 Patient care reverse isolation

chamber. 880.5475 Jet lavage. 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 mat

tress. 880.5570 Hypodermic single lumen needle. 880.5580 Acupuncture 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. 880.5960 Lice removal kit. 880.5965 Subcutaneous,

implanted, intravascular infusion port and catheter. 880.5970 Percutaneous, implanted, long-term

intravascular catheter.

880.6820 Medical disposable scissors.
880.6850 Sterilization wrap.
880.6860 Ethylene oxide gas sterilizer.
880.6870 Dry-heat sterilizer.
880.6880 Steam sterilizer.
880.6885 Liquid chemical sterilants

high level disinfectants. 880.6890 General purpose disinfectants. 880.6900 Hand-carried stretcher. 880.6910 Wheeled stretcher. 880.6920 Syringe needle introducer. 880.6960 Irrigating syringe. 880.6970 Liquid crystal vein locator. 880.6980 Vein stabilizer. 880.6990 Infusion stand.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

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

Subpart A-General Provisions

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. 880.6080 Cardiopulmonary resuscitation

board. 880.6085 Hot/cold water bottle. 880.6100 Ethylene oxide gas aerator cabinet. 880.6140 Medical chair and table. 880.6150 Ultrasonic cleaner for medical in

struments. 880.6175 (Reserved) 880.6185 Cast cover. 880.6190 Mattress cover for medical pur

poses. 880.6200 Ring cutter. 880.6230 Tongue depressor. 880.6250 Patient examination glove. 880.6265 Examination gown. 880.6280 Medical insole. 880.6320 AC-powered medical examination

light. 880.6350 Battery-powered medical examina

tion light. 880.6375 Patient lubricant. 880.6430 Liquid medication dispenser. 880.6450 Skin pressure protectors. 880.6500 Medical ultraviolet air purifier. 880.6710 Medical ultraviolet water purifier. 880.6730 Body waste receptacle. 880.6740 Vacuum-powered body fluid suction

apparatus. 880.6760 Protective restraint. 880.6775 Powered patient transfer device. 880.6785 Manual patient transfer device. 880.6800 Washers for body waste receptacles.

8880.1 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 regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the deunder section 515 of the act consists of vice must have an approval under secFDA's issuance of an order approving tion 515 of the act before commercial an application for premarket approval

distribution. (PMA) for the device or declaring completed a product development protocol

(52 FR 17738, May 11, 1987) (PDP) for the device. (a) Before FDA requires that a device

$880.9 Limitations of exemptions from commercially distributed before the

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). enactment date of the amendments, or a device that has been found substan- The exemption from the requirement tially equivalent to such a device, has of premarket notification (section an approval under section 515 of the act 510(k) of the act) for a generic type of FDA must promulgate a regulation class I or II device is only to the extent under section 515(b) of the act requir- that the device has existing or reasoning such approval, except as provided ably foreseeable characteristics of in paragraph (b) of this section. Such a

commercially distributed devices withregulation under section 515(b) of the

in that generic type or, in the case of act shall not be effective during the

in vitro diagnostic devices, only to the grace period ending on the 90th day

extent that misdiagnosis as a result of after its promulgation or on the last

using the device would not be associday of the 30th full calendar month

ated with high morbidity or mortality. after the regulation that classifies the

Accordingly, manufacturers of any device into class III is effective, which

commercially distributed class I or II ever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effec

device for which FDA has granted an tive date of the requirement for pre

exemption from the requirement of market approval is shown in the regu

premarket notification must still sublation for a device classified into class

mit a premarket notification to FDA III in this part, the device may be com

before introducing or delivering for inmercially distributed without FDA's troduction into interstate commerce issuance of an order approving a PMA for commercial distribution the device or declaring completed a PDP for the when: device. If FDA promulgates a regula- (a) The device is intended for a use tion under section 515(b) of the act re- different from the intended use of a lequiring premarket approval for a de- gally marketed device in that generic vice, section 501(f)(1)(A) of the act ap- type of device; e.g., the device is inplies to the device.

tended for a different medical purpose, (b) Any new, not substantially equiv- or the device is intended for lay use alent, device introduced into commer- where the former intended use was by cial distribution on or after May 28,

health care professionals only; 1976, including a device formerly mar

(b) The modified device operates keted that has been substantially al

using different fundamental scitered, is classified by statute (section

entific technology than a legally mar513(f) of the act) into class III without

keted device in that generic type of deany grace period and FDA must have

vice; e.g., a surgical instrument cuts issued an order approving a PMA or de

tissue with a laser beam rather than claring completed a PDP for the device before the device is commercially dis

with a sharpened metal blade, or an in tributed unless it is reclassified. If

vitro diagnostic device detects or idenFDA knows that a device being com

tifies infectious agents by using mercially distributed may be a "new"

deoxyribonucleic acid (DNA) probe or devices defined in this section because

nucleic acid hybridization technology of any new intended use or other rea

rather than culture or immunoassay sons, FDA may codify the statutory technology; or classification of the device into class (c) The device is an in vitro device III for such new use. Accordingly, the that is intended:

a

in subpart E of part 807 of this chapter subject to $ 880.9.

eases

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]

as

а.

(1) For use in the diagnosis, monitoring, or screening of neoplastic dis

with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves

surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as

acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in 8812.3(k) of this chapter; and

(9) For near patient testing (point of care).

$ 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)

8880.2420 Electronic monitor for grav.

ity 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).

[65 FR 2318, Jan. 14, 2000)

Subpart B [Reserved]

Subpart C-General Hospital and Personal Use Monitoring Devices

8880.2460 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).

8 880.2200 Liquid crystal forehead tem

perature 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 (special controls). The device is exempt from the premarket notification procedures

8 880.2500 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).

general requirements concerning records, and $ 820.198, with respect to complaint files.

8880.2700 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.

8880.2720 Patient scale.

(a) Identification. A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes devices placed under a bed or chair to weigh both the support and the patient, devices where the patient is lifted by a sling from a bed to be weighed, and devices where the patient is placed on the scale platform to be weighed. The device may be mechanical, battery powered, or AC-powered and may include transducers, electronic signal amplification, conditioning and display equipment.

(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 61 FR 1123, Jan. 16, 1996)

$880.2800 Sterilization process indi

cator. (a) Biological sterilization process indicator—(1) Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

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

(b) Physical/chemical sterilization process indicator-(1) Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

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

use

$ 880.2740 Surgical sponge scale.

(a) Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

(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

$880.2900 Clinical color change ther

mometer. (a) Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.

(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 61 FR 1123, Jan. 16, 1996)

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