[Title 21 CFR 880]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falseGENERAL HOSPITAL AND PERSONAL USE DEVICES880PART 880FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
Subpart A--General Provisions
Sec.
880.1 Scope.
880.3 Effective dates of requirement for premarket approval.
880.9 Limitations of exemptions from section 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 temperature 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
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 injector.
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 mattress.
880.5570 Hypodermic single lumen needle.
880.5580 Acupuncture needle.
880.5630 Nipple shield.
880.5640 Lamb feeding nipple.
880.5680 Pediatric position holder.
[[Page 367]]
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.
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 instruments.
880.6175 [Reserved]
880.6185 Cast cover.
880.6190 Mattress cover for medical purposes.
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 examination 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.
880.6900 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, 360c, 360e, 360j, 371.
Source: 45 FR 69682-69737, Oct. 21, l980, unless otherwise noted.
Subpart A--General Provisions
Sec. 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
Sec. 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]
Sec. 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
[[Page 368]]
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]
Sec. 880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
(a) 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:
(1) 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; or
(2) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(b) The exemption from the requirement of premarket notification for
a generic type of class II device applies only to those class II devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. A class II device for which FDA has granted an exemption
from the requirement of premarket notification must still submit a
premarket notification when:
(1) The device is intended for a use different from the intended use
of a legally marketed device in that generic
[[Page 369]]
type of device; 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; or
(2) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro diagnostic
device detects or identifies infectious agents by using deoxyribonucleic
acid (DNA) probe or nucleic acid hybridization technology rather than
culture or immunoassay technology; or
(3) The device is an in vitro device that is intended:
(i) For use in the diagnosis, monitoring, or screening of neoplastic
diseases with the exception of immunohistochemical devices;
(ii) For use in screening or diagnosis of familial and acquired
genetic disorders, including inborn errors of metabolism;
(iii) For measuring an analyte that serves as a 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;
(iv) For assessing the risk of cardiovascular diseases;
(v) For use in diabetes management;
(vi) For identifying or inferring the identity of a microorganism
directly from clinical material;
(vii) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) and 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;
(viii) For noninvasive testing; and
(ix) For near patient testing (point of care).
[54 FR 25050, June 12, 1989, as amended at 63 FR 59228, Nov. 3, 1998]
Subpart B [Reserved]
Subpart C--General Hospital and Personal Use Monitoring Devices
Sec. 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 (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59228, Nov. 3,
1998]
Sec. 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, l980, as amended at 59 FR 63010, Dec. 7,
1994]
Sec. 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).
Sec. 880.2460 Electrically powered spinal fluid pressure monitor.
(a) Identification. An electrically powered spinal fluid pressure
monitor is an
[[Page 370]]
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).
Sec. 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).
Sec. 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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.2720 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, l980, as amended at 61 FR 1123, Jan. 16,
1996]
Sec. 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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.2800 Sterilization process indicator.
(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.
[[Page 371]]
(2) Classification. Class II (performance standards).
Sec. 880.2900 Clinical color change thermometer.
(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 use 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, l980, as amended at 61 FR 1123, Jan. 16,
1996]
Sec. 880.2910 Clinical electronic thermometer.
(a) Identification. A clinical electronic thermometer is a device
used to measure the body temperature of a patient by means of a
transducer coupled with an electronic signal amplification,
conditioning, and display unit. The transducer may be in a detachable
probe with or without a disposable cover.
(b) Classification. Class II (performance standards).
Sec. 880.2920 Clinical mercury thermometer.
(a) Identification. A clinical mercury thermometer is a device used
to measure oral, rectal, or axillary (armpit) body temperature using the
thermal expansion of mercury.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59228, Nov. 3,
1998]
Sec. 880.2930 Apgar timer.
(a) Identification. The Apgar timer is a device intended to alert a
health care provider to take the Apgar score of a newborn infant.
(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 Sec. 880.9. The device is
also exempt from the current good manufacturing practice requirements in
part 820 of this chapter, with the exception of Sec. 820.180 of this
chapter, with respect to general requirements concerning records, and
Sec. 820.198 of this chapter, with respect to complaint files.
[63 FR 59718, Nov. 5, 1998]
Subparts D-E [Reserved]
Subpart F--General Hospital and Personal Use Therapeutic Devices
Sec. 880.5025 I.V. container.
(a) Identification. An I.V. container is a container made of plastic
or glass used to hold a fluid mixture to be administered to a patient
through an intravascular administration set.
(b) Classification. Class II (performance standards).
Sec. 880.5045 Medical recirculating air cleaner.
(a) Identification. A medical recirculating air cleaner is a device
used to remove particles from the air for medical purposes. The device
may function by electrostatic precipitation or filtration.
(b) Classification. Class II (performance standards).
Sec. 880.5075 Elastic bandage.
(a) Identification. An elastic bandage is a device consisting of
either a long flat strip or a tube of elasticized material that is used
to support and compress a part of a patient's body.
(b) Classification. Class I (general controls). The device is exempt
from premarket notification procedures in subpart E of part 807. If the
device is not labeled or otherwise represented as sterile, it also is
exempt from the good manufacturing practice regulation in part 820, with
the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.5090 Liquid bandage.
(a) Identification. A liquid bandage is a sterile device that is a
liquid,
[[Page 372]]
semiliquid, or powder and liquid combination used to cover an opening in
the skin or as a dressing for burns. The device is also used as a
topical skin protectant.
(b) Classification. Class I (general controls).
Sec. 880.5100 AC-powered adjustable hospital bed.
(a) Identification. An AC-powered adjustable hospital bed is a
device intended for medical purposes that consists of a bed with a
built-in electric motor and remote controls that can be operated by the
patient to adjust the height and surface contour of the bed. The device
includes movable and latchable side rails.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
Sec. 880.5110 Hydraulic adjustable hospital bed.
(a) Identification. A hydraulic adjustable hospital bed is a device
intended for medical purposes that consists of a bed with a hydraulic
mechanism operated by an attendant to adjust the height and surface
contour of the bed. The device includes movable and latchable side
rails.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
Sec. 880.5120 Manual adjustable hospital bed.
(a) Identification. A manual adjustable hospital bed is a device
intended for medical purposes that consists of a bed with a manual
mechanism operated by an attendant to adjust the height and surface
contour of the bed. The device includes movable and latchable side
rails.
(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
Sec. 820.180, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12,
1989]
Sec. 880.5130 Infant radiant warmer.
(a) Identification. The infant radiant warmer is a device consisting
of an infrared heating element intended to be placed over an infant to
maintain the infant's body temperature by means of radiant heat. The
device may also contain a temperature monitoring sensor, a heat output
control mechanism, and an alarm system (infant temperature, manual mode
if present, and failure alarms) to alert operators of a temperature
condition over or under the set temperature, manual mode time limits,
and device component failure, respectively. The device may be placed
over a pediatric hospital bed or it may be built into the bed as a
complete unit.
(b) Classification. Class II (Special Controls):
(1) The Association for the Advancement of Medical Instrumentation
(AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with Sec. 801.109 of this
chapter (restricted to use by or upon the order of qualified
practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by
persons with specific training and experience in the use of the device.
[62 FR 33350, June 19, 1997]
Sec. 880.5140 Pediatric hospital bed.
(a) Identification. A pediatric hospital bed is a device intended
for medical purposes that consists of a bed or crib designed for the use
of a pediatric patient, with fixed end rails and movable and latchable
side rails. The contour of the bed surface may be adjustable.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
[[Page 373]]
Sec. 880.5150 Nonpowered flotation therapy mattress.
(a) Identification. A nonpowered flotation therapy mattress is a
mattress intended for medical purposes which contains air, fluid, or
other materials that have the functionally equivalent effect of
supporting a patient and avoiding excess pressure on local body areas.
The device is intended to treat or prevent decubitus ulcers (bed sores).
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.5160 Therapeutic medical binder.
(a) Identification. A therapeutic medical binder is a device,
usually made of cloth, that is intended for medical purposes and that
can be secured by ties so that it supports the underlying part of the
body or holds a dressing in place. This generic type of device includes
the abdominal binder, breast binder, and perineal binder.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notifiction procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.5180 Burn sheet.
(a) Identification. A burn sheet is a device made of a porous
material that is wrapped aroung a burn victim to retain body heat, to
absorb wound exudate, and to serve as a barrier against contaminants.
(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, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5200 Intravascular catheter.
(a) Identification. An intravascular catheter is a device that
consists of a slender tube and any necessary connecting fittings and
that is inserted into the patient's vascular system for short term use
(less than 30 days) to sample blood, monitor blood pressure, or
administer fluids intravenously. The device may be constructed of metal,
rubber, plastic, or a combination of these materials.
(b) Classification. Class II (performance standards).
Sec. 880.5210 Intravascular catheter securement device.
(a) Identification. An intravascular catheter securement device is a
device with an adhesive backing that is placed over a needle or catheter
and is used to keep the hub of the needle or the catheter flat and
securely anchored to the skin.
(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, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5240 Medical adhesive tape and adhesive bandage.
(a) Identification. A medical adhesive tape or adhesive bandage is a
device intended for medical purposes that consists of a strip of fabric
material or plastic, coated on one side with an adhesive, and may
include a pad of surgical dressing without a disinfectant. The device is
used to cover and protect wounds, to hold together the skin edges of a
wound, to support an injured part of the body, or to secure objects to
the skin.
(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, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5270 Neonatal eye pad.
(a) Identification. A neonatal eye pad is an opaque device used to
cover and protect the eye of an infant during therapeutic procedures,
such as phototherapy.
[[Page 374]]
(b) Classification. Class I (general controls). If the device is not
labeled or otherwise represented as sterile, it is exempt from the good
manufacturing practice regulation part 820, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
Sec. 880.5300 Medical absorbent fiber.
(a) Identification. A medical absorbent fiber is a device intended
for medical purposes that is made from cotton or synthetic fiber in the
shape of a ball or a pad and that is used for applying medication to, or
absorbing small amounts of body fluids from, a patient's body surface.
Absorbent fibers intended solely for cosmetic purposes are not included
in this generic device category.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.5400 Neonatal incubator.
(a) Identification. A neonatal incubator is a device consisting of a
rigid boxlike enclosure in which an infant may be kept in a controlled
environment for medical care. The device may include an AC-powered
heater, a fan to circulate the warmed air, a container for water to add
humidity, a control valve through which oxygen may be added, and access
ports for nursing care.
(b) Classification. Class II (performance standards).
Sec. 880.5410 Neonatal transport incubator.
(a) Identification. A neonatal transport incubator is a device
consisting of a portable rigid boxlike enclosure with insulated walls in
which an infant may be kept in a controlled environment while being
transported for medical care. The device may include straps to secure
the infant, a battery-operated heater, an AC-powered battery charger, a
fan to circulate the warmed air, a container for water to add humidity,
and provision for a portable oxygen bottle.
(b) Classification. Class II (performance standards).
Sec. 880.5420 Pressure infusor for an I.V. bag.
(a) Identification. A pressure infusor for an I.V. bag is a device
consisting of an inflatable cuff which is placed around an I.V. bag.
When the device is inflated, it increases the pressure on the I.V. bag
to assist the infusion of the fluid.
(b) Classification. Class I (general controls).
Sec. 880.5430 Nonelectrically powered fluid injector.
(a) Identification. A nonelectrically powered fluid injector is a
nonelectrically powered device used by a health care provider to give a
hypodermic injection by means of a narrow, high velocity jet of fluid
which can penetrate the surface of the skin and deliver the fluid to the
body. It may be used for mass inoculations.
(b) Classification. Class II (performance standards).
Sec. 880.5440 Intravascular administration set.
(a) Identification. An intravascular administration set is a device
used to administer fluids from a container to a patient's vascular
system through a needle or catheter inserted into a vein. The device may
include the needle or catheter, tubing, a flow regulator, a drip
chamber, an infusion line filter, an I.V. set stopcock, fluid delivery
tubing, connectors between parts of the set, a side tube with a cap to
serve as an injection site, and a hollow spike to penetrate and connect
the tubing to an I.V. bag or other infusion fluid container.
(b) Classification. Class II (performance standards).
Sec. 880.5450 Patient care reverse isolation chamber.
(a) Identification. A patient care reverse isolation chamber is a
device
[[Page 375]]
consisting of a roomlike enclosure designed to prevent the entry of
harmful airborne material. This device protects a patient who is
undergoing treatment for burns or is lacking a normal immunosuppressive
defense due to therapy or congenital abnormality. The device includes
fans and air filters which maintain an atmosphere of clean air at a
pressure greater than the air pressure outside the enclosure.
(b) Classification. Class II (performance standards).
Sec. 880.5475 Jet lavage.
(a) Identification. A jet lavage is a device used to clean a wound
by a pulsatile jet of sterile fluid. The device consists of the pulsing
head, tubing to connect to a container of sterile fluid, and a means of
propelling the fluid through the tubing, such as an electric roller
pump.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
Sec. 880.5500 AC-powered patient lift.
(a) Identification. An AC-powered lift is an electrically powered
device either fixed or mobile, used to lift and transport patients in
the horizontal or other required position from one place to another, as
from a bed to a bath. The device includes straps and slings to support
the patient.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
Sec. 880.5510 Non-AC-powered patient lift.
(a) Identification. A non-AC-powered patient lift is a hydraulic,
battery, or mechanically powered device, either fixed or mobile, used to
lift and transport a patient in the horizontal or other required
position from one place to another, as from a bed to a bath. The device
includes straps and a sling to support the patient.
(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 54 FR 25050, June 12,
1989]
Sec. 880.5550 Alternating pressure air flotation mattress.
(a) Identification. An alternating pressure air flotation mattress
is a device intended for medical purposes that consists of a mattress
with multiple air cells that can be filled and emptied in an alternating
pattern by an associated control unit to provide regular, frequent, and
automatic changes in the distribution of body pressure. The device is
used to prevent and treat decubitus ulcers (bed sores).
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
Sec. 880.5560 Temperature regulated water mattress.
(a) Identification. A temperature regulated water mattress is a
device intended for medical purposes that consists of a mattress of
suitable size, filled with water which can be heated or in some cases
cooled. The device includes electrical heating and water circulating
components, and an optional cooling component. The temperature control
may be manual or automatic.
(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, l980, as amended at 61 FR 1123, Jan. 16,
1996]
Sec. 880.5570 Hypodermic single lumen needle.
(a) Identification. A hypodermic single lumen needle is a device
intended to inject fluids into, or withdraw fluids from, parts of the
body below the surface of the skin. The device consists of a metal tube
that is sharpened at one
[[Page 376]]
end and at the other end joined to a female connector (hub) designed to
mate with a male connector (nozzle) of a piston syringe or an
intravascular administration set.
(b) Classification. Class II (performance standards).
Sec. 880.5580 Acupuncture needle.
(a) Identification. An acupuncture needle is a device intended to
pierce the skin in the practice of acupuncture. The device consists of a
solid, stainless steel needle. The device may have a handle attached to
the needle to facilitate the delivery of acupuncture treatment.
(b) Classification. Class II (special controls). Acupuncture needles
must comply with the following special controls:
(1) Labeling for single use only and conformance to the requirements
for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.
[61 FR 64617, Dec. 6, 1996]
Sec. 880.5630 Nipple shield.
(a) Identification. A nipple shield is a device consisting of a
cover used to protect the nipple of a nursing woman. This generic device
does not include nursing pads intended solely to protect the clothing of
a nursing woman from milk.
(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, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5640 Lamb feeding nipple.
(a) Identification. A lamb feeding nipple is a device intended for
use as a feeding nipple for infants with oral or facial abnormalities.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.5680 Pediatric position holder.
(a) Identification. A pediatric position holder is a device used to
hold an infant or a child in a desired position for therapeutic or
diagnostic purposes, e.g., in a crib under a radiant warmer, or to
restrain a child while an intravascular injection is administered.
(b) Classification. Class I (general controls). The device is exempt
from the good manufacturing practice regulation in part 820, with the
exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.5700 Neonatal phototherapy unit.
(a) Identification. A neonatal phototherapy unit is a device used to
treat or prevent hyperbilirubinemia (elevated serum bilirubin level).
The device consists of one or more lamps that emit a specific spectral
band of light, under which an infant is placed for therapy. This generic
type of device may include supports for the patient and equipment and
component parts.
(b) Classification. Class II (performance standards).
Sec. 880.5725 Infusion pump.
(a) Identification. An infusion pump is a device used in a health
care facility to pump fluids into a patient in a controlled manner. The
device may use a piston pump, a roller pump, or a peristaltic pump and
may be powered electrically or mechanically. The device may also operate
using a constant force to propel the fluid through a narrow tube which
determines the flow rate. The device may include means to detect a fault
condition, such as air in, or blockage of, the infusion line and to
activate an alarm.
(b) Classification. Class II (performance standards).
Sec. 880.5740 Suction snakebite kit.
(a) Identification. A suction snakebite kit is a device consisting
of a knife, suction device, and tourniquet used for
[[Page 377]]
first-aid treatment of snakebites by removing venom from the wound.
(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, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5760 Chemical cold pack snakebite kit.
(a) Identification. A chemical cold pack snakebit kit is a device
consisting of a chemical cold pack and tourniquet used for first-aid
treatment of snakebites.
(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 chemical
cold pack snakebite kit 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 a chemical cold pack snakebite kit that was
in commercial distribution before May 28, 1976. Any other chemical cold
pack snakebite kit shall have an approved PMA or a declared completed
PDP in effect before being placed in commercial distribution.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 52 FR 17739, May 11,
1987; 61 FR 50708, Sept. 27, 1996]
Sec. 880.5780 Medical support stocking.
(a) Medical support stocking to prevent the pooling of blood in the
legs--(1) Identification. A medical support stocking to prevent the
pooling of blood in the legs is a device that is constructed of elastic
material and designed to apply controlled pressure to the leg and that
is intended for use in the prevention of pooling of blood in the leg.
(2) Classification. Class II (performance standards).
(b) Medical support stocking for general medical purposes--(1)
Identification. A medical support stocking for general medical purposes
is a device that is constructed of elastic material and designed to
apply controlled pressure to the leg and that is intended for medical
purposes other than the prevention of pooling of blood in the leg.
(2) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5820 Therapeutic scrotal support.
(a) Identification. A therapeutic scrotal support is a device
intended for medical purposes that consist of a pouch attached to an
elastic waistband and that is used to support the scrotum (the sac that
contains the testicles).
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.5860 Piston syringe.
(a) Identification. A piston syringe is a device intended for
medical purposes that consists of a calibrated hollow barrel and a
movable plunger. At one end of the barrel there is a male connector
(nozzle) for fitting the female connector (hub) of a hypodermic single
lumen needle. The device is used to inject fluids into, or withdraw
fluids from, the body.
(b) Classification. Class II (performance standards).
Sec. 880.5950 Umbilical occlusion device.
(a) Identification. An umbilical occlusion device is a clip, tie,
tape, or other article used to close the blood vessels in the umbilical
cord of a newborn infant.
[[Page 378]]
(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, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.5960 Lice removal kit.
(a) Identification. The lice removal kit is a comb or comb-like
device intended to remove and/or kill lice and nits from head and body
hair. It may or may not be battery operated.
(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 Sec. 880.9.
[63 FR 59718, Nov. 5, 1998]
Subpart G--General Hospital and Personal Use Miscellaneous Devices
Sec. 880.6025 Absorbent tipped applicator.
(a) Identification. An absorbent tipped applicator is a device
intended for medical purposes that consists of an absorbent swab on a
wooden, paper, or plastic stick. The device is used to apply medications
to, or to take specimens from, a patient.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.6050 Ice bag.
(a) Identification. An ice bag is a device intended for medical
purposes that is in the form of a container intended to be filled with
ice that is used to apply dry cold therapy to an area of the body. The
device may include a holder that keeps the bag in place against an
external area of the patient.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.6060 Medical disposable bedding.
(a) Identification. Medical disposable bedding is a device intended
for medical purposes to be used by one patient for a period of time and
then discarded. This generic type of device may include disposable
bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue
blankets, or waterproof sheets.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. If the
device is not labeled or otherwise represented as sterile, it is exempt
from the current good manufacturing practice regulations in part 820 of
this chapter, with the exception of Sec. 820.180, with respect to
general requirements concerning records, and Sec. 820.198, with respect
to complaint files.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.6070 Bed board.
(a) Identification. A bed board is a device intended for medical
purposes that consists of a stiff board used to increase the firmness of
a bed.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6080 Cardiopulmonary resuscitation board.
(a) Identification. A cardiopulmonary resuscitation board is a
device consisting of a rigid board which is placed under a patient to
act as a support during cardiopulmonary resuscitation.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in
[[Page 379]]
subpart E of part 807. The device also is exempt from the good
manufacturing practice regulation in part 820, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
Sec. 880.6085 Hot/cold water bottle.
(a) Identification. A hot/cold water bottle is a device intended for
medical purposes that is in the form of a container intended to be
filled with hot or cold water to apply heat or cold to an area of the
body.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6100 Ethylene oxide gas aerator cabinet.
(a) Identification. An ethyene oxide gas aerator cabinet is a device
that is intended for use by a health care provider and consists of a
cabinet with a ventilation system designed to circulate and exchange the
air in the cabinet to shorten the time required to remove residual
ethylene oxide (ETO) from wrapped medical devices that have undergone
ETO sterilization. The device may include a heater to warm the
circulating air.
(b) Classification. Class II (performance standards).
Sec. 880.6140 Medical chair and table.
(a) Identification. A medical chair or table is a device intended
for medical purposes that consists of a chair or table without wheels
and not electrically powered which, by reason of special shape or
attachments, such as food trays or headrests, or special features such
as a built-in raising and lowering mechanism or removable arms, is
intended for use of blood donors, geriatric patients, or patients
undergoing treatment or examination.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6150 Ultrasonic cleaner for medical instruments.
(a) Identification. An ultrasonic cleaner for medical instruments is
a device intended for cleaning medical instruments by the emission of
high frequency soundwaves.
(b) Classification. Class I. The device, including any solutions
intended for use with the device for cleaning and sanitizing the
instruments, 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 54 FR 25050, June 12,
1989; 59 FR 63011, Dec. 7, 1994]
Sec. 880.6175 [Reserved]
Sec. 880.6185 Cast cover.
(a) Identification. A cast cover is a device intended for medical
purposes that is made of waterproof material and placed over a cast to
protect it from getting wet during a shower or a bath.
(b) Classification. Class I (general controls). The device is exempt
from premarket notification procedures in subpart 807. If the device is
not labeled or otherwise represented as sterile it is also exempt from
the good manufacturing practice regulation in part 820, with the
exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.6190 Mattress cover for medical purposes.
(a) Identification. A mattress cover for medical purposes is a
device intended for medical purposes that is used to protect a mattress.
It may be electrically conductive or contain a germicide.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807
[[Page 380]]
of this chapter. If the device is not labeled or otherwise represented
as sterile, it is exempt from the good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.6200 Ring cutter.
(a) Identification. A ring cutter is a device intended for medical
purposes that is used to cut a ring on a patient's finger so that the
ring can be removed. The device incorporates a guard to prevent injury
to the patient's finger.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6230 Tongue depressor.
(a) Identification. A tongue depressor is a device intended to
displace the tongue to facilitate examination of the surrounding organs
and tissues.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.6250 Patient examination glove.
(a) Identification. A patient examination glove is a disposable
device intended for medical purposes that is worn on the examiner's hand
or finger to prevent contamination between patient and examiner.
(b) Classification. Class I (general controls).
[45 FR 69682-69737, Oct. 21, 1980, as amended at 53 FR 1604, Jan. 13,
1989]
Sec. 880.6265 Examination gown.
(a) Identification. An examination gown is a device intended for
medical purposes that is made of cloth, paper, or other material that is
draped over or worn by a patient as a body covering during a medical
examination.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.6280 Medical insole.
(a) Identification. A medical insole is a device intended for
medical purposes that is placed inside a shoe to relieve the symptoms of
athlete's foot infection by absorbing moisture.
(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 54 FR 25050, June 12,
1989]
Sec. 880.6320 AC-powered medical examination light.
(a) Identification. An AC-powered medical examination light is an
AC-powered device intended for medical purposes that is used to
illuminate body surfaces and cavities during a medical examination.
(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, l980, as amended at 61 FR 1123, Jan. 16,
1996]
Sec. 880.6350 Battery-powered medical examination light.
(a) Identification. A battery-powered medical examination light is a
battery-powered device intended for medical purposes that is used to
illuminate body surfaces and cavities during a medical examination.
[[Page 381]]
(b) Classification. Class I (general controls). The device is exempt
from 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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6375 Patient lubricant.
(a) Identification. A patient lubricant is a device intended for
medical purposes that is used to lubricate a body orifice to facilitate
entry of a diagnostic or therapeutic device.
(b) Classification. Class I (general controls).
Sec. 880.6430 Liquid medication dispenser.
(a) Identification. A Liquid medication dispenser is a device
intended for medical purposes that is used to issue a measured amount of
liquid medication.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6450 Skin pressure protectors.
(a) Identification. A skin pressure protector is a device intended
for medical purposes that is used to reduce pressure on the skin over a
bony prominence to reduce the likelihood of the patient's developing
decubitus ulcers (bedsores).
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6500 Medical ultraviolet air purifier.
(a) Identification. A medical ultraviolet air purifier is a device
intended for medical purposes that is used to destroy bacteria in the
air by exposure to ultraviolet radiation.
(b) Classification. Class II (performance standards).
Sec. 880.6710 Medical ultraviolet water purifier.
(a) Identification. A medical ultraviolet water purifier is a device
intended for medical purposes that is used to destroy bacteria in water
by exposure to ultraviolet radiation.
(b) Classification. Class II (performance standards).
Sec. 880.6730 Body waste receptacle.
(a) Identification. A body waste receptacle is a device intended for
medical purposes tht is not attached to the body and that is used to
collect the body wastes of a bed patient.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6740 Vacuum-powered body fluid suction apparatus.
(a) Identification. A vacuum-powered body fluid suction apparatus is
a device used to aspirate, remove, or sample body fluids. The device is
powered by an external source of vacuum. This generic type of device
includes vacuum regulators, vacuum collection bottles, suction catheters
and tips, connecting flexible aspirating tubes, rigid suction tips,
specimen traps, noninvasive tubing, and suction regulators (with gauge).
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
[[Page 382]]
Sec. 880.6760 Protective restraint.
(a) Identification. A protective restraint is a device, including
but not limited to a wristlet, anklet, vest, mitt, straight jacket,
body/limb holder, or other type of strap, that is intended for medical
purposes and that limits the patient's movements to the extent necessary
for treatment, examination, or protection of the patient or others.
(b) Classification. Class I (general controls).
[61 FR 8439, Mar. 4, 1996]
Sec. 880.6775 Powered patient transfer device.
(a) Identification. A powered patient transfer device is a device
consisting of a wheeled stretcher and a powered mechanism that has a
broad, flexible band stretched over long rollers that can advance itself
under a patient and transfer the patient with minimal disturbance in a
horizontal position to the stretcher.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
Sec. 880.6785 Manual patient transfer device.
(a) Identification. A manual patient transfer device is a device
consisting of a wheeled stretcher and a mechanism on which a patient can
be placed so that the patient can be transferred with minimal
disturbance in a horizontal position to the stretcher.
(b) Classification. Class I (general controls). The device is exempt
from premarket notification procedures in subpart E of part 807. The
divice also is exempt from the good manufacturing practice regulation in
part 820, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6800 Washers for body waste receptacles.
(a) Identification. A washer for body waste receptacles is a device
intended for medical purposes that is used to clean and sanitize a body
waste receptacle, such as a bedpan. The device consists of a wall-
mounted plumbing fixture with a door through which a body waste
receptacle is inserted. When the door is closed the body waste
receptacle is cleaned by hot water, steam, or germicide.
(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 Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 880.6820 Medical disposable scissors.
(a) Identification. Medical disposable scissors are disposable type
general cutting devices intended for medical purposes. This generic type
of device does not include surgical scissors.
(b) Classification. Class I (general controls). The device is exempt
from premarket notification procedures in subpart E of part 807.
Sec. 880.6850 Sterilization wrap.
(a) Identification. A sterilization wrap (pack, sterilization
wrapper, bag, or accessories, is a device intended to be used to enclose
another medical device that is to be sterilized by a health care
provider. It is intended to allow sterilization of the enclosed medical
device and also to maintain sterility of the enclosed device until used.
(b) Classification. Class II (performance standards).
Sec. 880.6860 Ethylene oxide gas sterilizer.
(a) Identification. An ethylene gas sterilizer is a nonportable
device intended for use by a health care provider that uses ethylene
oxide (ETO) to sterilize medical products.
(b) Classification. Class II (performance standards).
Sec. 880.6870 Dry-heat sterilizer.
(a) Identification. A dry-heat sterilizer is a device that is
intended for use by a health care provider to sterilize medical products
by means of dry heat.
[[Page 383]]
(b) Classification. Class II (performance standards).
Sec. 880.6880 Steam sterilizer.
(a) Identification. A steam sterilizer (autoclave) is a device that
is intended for use by a health care provider to sterilize medical
products by means of pressurized steam.
(b) Classification. Class II (performance standards).
Sec. 880.6900 Hand-carried stretcher.
(a) Identification. A hand-carried stretcher is a device consisting
of a lightweight frame, or of two poles with a cloth or metal platform,
on which a patient can be carried.
(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 exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7,
1994]
Sec. 880.6910 Wheeled stretcher.
(a) Identification. A wheeled stretcher is a device consisting of a
platform mounted on a wheeled frame that is designed to transport
patients in a horizontal position. The device may have side rails,
supports for fluid infusion equipment, and patient securement straps.
The frame may be fixed or collapsible for use in an ambulance.
(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 Sec. 880.9.
[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59229, Nov. 3,
1998]
Sec. 880.6920 Syringe needle introducer.
(a) Identification. A syringe needle introducer is a device that
uses a spring-loaded mechanism to drive a hypodermic needle into a
patient to a predetermined depth below the skin surface.
(b) Classification. Class II (performance standards).
Sec. 880.6960 Irrigating syringe.
(a) Identification. An irrigating syringe is a device intended for
medical purposes that consists of a bulb or a piston syringe with an
integral or a detachable tube. The device is used to irrigate, withdraw
fluid from, or instill fluid into, a body cavity or wound.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 880.6970 Liquid crystal vein locator.
(a) Identification. A liquid crystal vein locator is a device used
to indicate the location of a vein by revealing variations in the
surface temperature of the skin by displaying the color changes of heat
sensitive liquid crystals (cholesteric esters).
(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 54 FR 25050, June 12,
1989]
Sec. 880.6980 Vein stabilizer.
(a) Identification. A vein stabilizer is a device consisting of a
flat piece of plastic with two noninvasive prongs. The device is placed
on the skin so that the prongs are on either side of a vein and hold it
stable while a hypodermic needle is inserted into the vein.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it is
also exempt from the good manufacturing practice regulation in part 820,
with the exception of Sec. 820.180, general requirements concerning
records, and Sec. 820.198, with respect to complaint files.
[[Page 384]]
Sec. 880.6990 Infusion stand.
(a) Identification. The infusion stand is a stationary or movable
stand intended to hold infusion liquids, infusion accessories, and other
medical devices.
(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 Sec. 880.9.
[63 FR 59718, Nov. 5, 1998]