« iepriekšējāTurpināt »
Subpart F-General Hospital and Personal
Use Therapeutic Devices
subpart E of part 807 of this chapter, subject to the limitations in 8 878.9. (53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001)
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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in $878.9. (53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001)
PART 880–GENERAL HOSPITAL AND PERSONAL USE 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 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. 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
Subpart A-General Provisions
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).
Subpart B [Reserved]
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.
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.
Subparts D-E [Reserved]
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. 880.6300 Implantable radiofrequency trans
ponder system for patient identification
and health information. 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. 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. 880.6991 Medical washer. 880.6992 Medical washer-disinfector.
AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360), 371.
SOURCE: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
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.
(e) Guidance documents referenced in this part are available on the Internet at
http://www.fda.gov/cdrh/guidance.html. (52 FR 17738, May 11, 1987, as amended at 69 FR 71704, Dec. 8, 2004)
$ 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
Subpart A-General Provisions $880.1 Scope.
(a) This part sets forth the classifica tion 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
after the regulation that classifies the commercially distributed class I or II device into class III is effective, which device for which FDA has granted an ever is later. See section 501(f)(2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still subtive date of the requirement for pre mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for inlation for a device classified into class troduction into interstate commerce III in this part, the device may be com for commercial distribution the device mercially distributed without FDA's when: issuance of an order approving a PMA (a) The device is intended for a use or declaring completed a PDP for the different from the intended use of a ledevice. If FDA promulgates a regula gally marketed device in that generic tion under section 515(b) of the act re- type of device; e.g., the device is inquiring premarket approval for a de tended for a different medical purpose, vice, section 501(f)(1)(A) of the act ap or the device is intended for lay use plies to the device.
where the former intended use was by (b) Any new, not substantially equiv- health care professionals only; alent, device introduced into commer (b) The modified device operates cial distribution on or after May 28, using a different fundamental sci1976, including a device formerly mar- entific technology than a legally marketed that has been substantially al
keted device in that generic type of detered, is classified by statute (section
vice; e.g., a surgical instrument cuts 513(f) of the act) into class III without
tissue with a laser beam rather than any grace period and FDA must have
with a sharpened metal blade, or an in issued an order approving a PMA or de
vitro diagnostic device detects or idenclaring completed a PDP for the device tifies infectious agents by using before the device is commercially dis
deoxyribonucleic acid (DNA) probe or tributed unless it is reclassified. If
nucleic acid hybridization technology FDA knows that a device being com- rather than culture or immunoassay mercially distributed may be a "new". technology; or devices defined in this section because (c) The device is an in vitro device of any new intended use or other rea
that is intended: sons, FDA may codify the statutory (1) For use in the diagnosis, moniclassification of the device into class
toring, or screening of neoplastic disIII for such new use. Accordingly, the
eases with the exception of regulation for such a class III device
immunohistochemical devices; states that as of the enactment date of
(2) For use in screening or diagnosis the amendments, May 28, 1976, the de- of familial or acquired genetic disvice must have an approval under sec orders, including inborn errors of metion 515 of the act before commercial
(3) For measuring an analyte that (52 FR 17738, May 11, 1987)
serves as a surrogate marker for
screening, diagnosis, or monitoring 8 880.9 Limitations of exemptions from life-threatening diseases such as ac
section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act).
(AIDS), chronic or active hepatitis, tuThe exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardioclass I or II device is only to the extent vascular diseases; that the device has existing or reason (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with identity of a microorganism directly in that generic type or, in the case of from clinical material; in vitro diagnostic devices, only to the (7) For detection of antibodies to extent that misdiagnosis as a result of microorganisms other than using the device would not be associ- immunoglobulin G (IgG) or IgG assays ated with high morbidity or mortality. when the results are not qualitative, or Accordingly, manufacturers of any 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 $812.3(k) of this chapter; and
(9) For near patient testing (point of care). [65 FR 2318, Jan. 14, 2000)
Subpart B [Reserved)
Subpart C-General Hospital and Personal Use Monitoring Devices $ 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 in subpart E of part 807 of this chapter subject to 880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]
amplification, conditioning, and display.
(b) Classification. Class II (performance standards). 8 880.2460 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). 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). $ 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 of this chapter, subject to the limitations in $ 880.9. The device also is 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. [45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 38803, July 25, 2001
$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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $ 880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]
8880.2420 Electronic monitor for gray
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
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, de- nisms to grow under suitable condivices where the patient is lifted by a tions indicates the adequacy of sterisling from a bed to be weighed, and de lization. vices where the patient is placed on the (2) Classification. Class II (performscale platform to be weighed. The de ance standards). vice may be mechanical, battery pow (b) Physical/chemical sterilization procered, or AC-powered and may include ess indicator—(1) Identification. A phystransducers, electronic signal amplifi- ical/chemical sterilization process indication, conditioning and display equip cator is a device intended for use by a ment.
health care provider to accompany (b) Classification. Class I (general con- products being sterilized through a trols). The device is exempt from the sterilization procedure and to monitor premarket notification procedures in one or more parameters of the sterisubpart E of part 807 of this chapter lization process. The adequacy of the subject to the limitations in 8880.9. sterilization conditions as measured by (45 FR 69682-69737, Oct. 21, 1980, as amended
these parameters is indicated by a visiat 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July
ble change in the device. 25, 2001)
(2) Classification. Class II (perform
ance standards). 8 880.2740 Surgical sponge scale.
(a) Identification. A surgical sponge $880.2900 Clinical color change ther: scale is a nonelectrically powered de
mometer. vice used to weigh surgical sponges
(a) Identification. A clinical color that have been used to absorb blood change thermometer is a disposable deduring surgery so that, by comparison vice used to measure a patient's oral, with the known dry weight of the rectal, or axillary (armpit) body temsponges, an estimate may be made of perature. The device records body temthe blood lost by the patient during perature by use of heat sensitive surgery.
chemicals which are sealed at the end (b) Classification. Class I (general con of a plastic or metal strip. Body heat trols). The device is exempt from the causes a stable color change in the premarket notification procedures in heat sensitive chemicals. subpart E of part 807 of this chapter, (b) Classification. Class I (general consubject to the limitations in 8 880.9. The trols). The device is exempt from the device also is exempt from the current premarket notification procedures in good manufacturing practice regula- subpart E of part 807 of this chapter, tions in part 820 of this chapter, with subject to the limitations in $ 880.9. the exception of $ 820.180, with respect
(45 FR 69682-69737, Oct. 21, 1980, as amended to general requirements concerning
at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July records, and $820.198, with respect to
25, 2001) complaint files. [45 FR 69682-69737, Oct. 21, 1980, as amended
$880.2910 Clinical electronic thermomat 66 FR 38804, July 25, 2001
(a) Identification. A clinical electronic 8880.2800 Sterilization process indi. thermometer is a device used to meascator.
ure the body temperature of a patient (a) Biological sterilization process indi- by means of a transducer coupled with cator—(1) Identification. A biological an electronic signal amplification, consterilization process indicator is a de- ditioning, and display unit. The transvice intended for use by a health care ducer may be in a detachable probe provider to accompany products being with or without a disposable cover. sterilized through a sterilization proce- (b) Classification. Class II (performdure and to monitor adequacy of steri- ance standards). lization. The device consists of a known number of microorganisms, of $880.2920 Clinical mercury thermomknown resistance to the mode of steri
eter. lization, in or on a carrier and enclosed (a) Identification. A clinical mercury in a protective package. Subsequent thermometer is a device used to measgrowth or failure of the microorga- ure oral, rectal, or axillary (armpit)