Title 21

PART 880

Part 880 - General Hospital And Personal Use Devices

PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:45 FR 69682, Oct. 21, 1980, unless otherwise noted. Editorial Note:Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.27.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.27.1.1.1SECTION 880.1
   880.1 Scope.
21:8.0.1.1.27.1.1.2SECTION 880.3
   880.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.27.1.1.3SECTION 880.9
   880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.27.2SUBPART B
Subpart B [Reserved]
21:8.0.1.1.27.3SUBPART C
Subpart C - General Hospital and Personal Use Monitoring Devices
21:8.0.1.1.27.3.1.1SECTION 880.2200
   880.2200 Liquid crystal forehead temperature strip.
21:8.0.1.1.27.3.1.2SECTION 880.2400
   880.2400 Bed-patient monitor.
21:8.0.1.1.27.3.1.3SECTION 880.2420
   880.2420 Electronic monitor for gravity flow infusion systems.
21:8.0.1.1.27.3.1.4SECTION 880.2460
   880.2460 Electrically powered spinal fluid pressure monitor.
21:8.0.1.1.27.3.1.5SECTION 880.2500
   880.2500 Spinal fluid manometer.
21:8.0.1.1.27.3.1.6SECTION 880.2700
   880.2700 Stand-on patient scale.
21:8.0.1.1.27.3.1.7SECTION 880.2720
   880.2720 Patient scale.
21:8.0.1.1.27.3.1.8SECTION 880.2740
   880.2740 Surgical sponge scale.
21:8.0.1.1.27.3.1.9SECTION 880.2750
   880.2750 Image processing device for estimation of external blood loss.
21:8.0.1.1.27.3.1.10SECTION 880.2800
   880.2800 Sterilization process indicator.
21:8.0.1.1.27.3.1.11SECTION 880.2900
   880.2900 Clinical color change thermometer.
21:8.0.1.1.27.3.1.12SECTION 880.2910
   880.2910 Clinical electronic thermometer.
21:8.0.1.1.27.3.1.13SECTION 880.2920
   880.2920 Clinical mercury thermometer.
21:8.0.1.1.27.3.1.14SECTION 880.2930
   880.2930 Apgar timer.
21:8.0.1.1.27.4SUBPART D
Subparts D-E [Reserved]
21:8.0.1.1.27.5SUBPART F
Subpart F - General Hospital and Personal Use Therapeutic Devices
21:8.0.1.1.27.5.1.1SECTION 880.5025
   880.5025 I.V. container.
21:8.0.1.1.27.5.1.2SECTION 880.5045
   880.5045 Medical recirculating air cleaner.
21:8.0.1.1.27.5.1.3SECTION 880.5075
   880.5075 Elastic bandage.
21:8.0.1.1.27.5.1.4SECTION 880.5090
   880.5090 Liquid bandage.
21:8.0.1.1.27.5.1.5SECTION 880.5100
   880.5100 AC-powered adjustable hospital bed.
21:8.0.1.1.27.5.1.6SECTION 880.5110
   880.5110 Hydraulic adjustable hospital bed.
21:8.0.1.1.27.5.1.7SECTION 880.5120
   880.5120 Manual adjustable hospital bed.
21:8.0.1.1.27.5.1.8SECTION 880.5130
   880.5130 Infant radiant warmer.
21:8.0.1.1.27.5.1.9SECTION 880.5140
   880.5140 Pediatric medical crib.
21:8.0.1.1.27.5.1.10SECTION 880.5145
   880.5145 Medical bassinet.
21:8.0.1.1.27.5.1.11SECTION 880.5150
   880.5150 Nonpowered flotation therapy mattress.
21:8.0.1.1.27.5.1.12SECTION 880.5160
   880.5160 Therapeutic medical binder.
21:8.0.1.1.27.5.1.13SECTION 880.5180
   880.5180 Burn sheet.
21:8.0.1.1.27.5.1.14SECTION 880.5200
   880.5200 Intravascular catheter.
21:8.0.1.1.27.5.1.15SECTION 880.5210
   880.5210 Intravascular catheter securement device.
21:8.0.1.1.27.5.1.16SECTION 880.5240
   880.5240 Medical adhesive tape and adhesive bandage.
21:8.0.1.1.27.5.1.17SECTION 880.5270
   880.5270 Neonatal eye pad.
21:8.0.1.1.27.5.1.18SECTION 880.5300
   880.5300 Medical absorbent fiber.
21:8.0.1.1.27.5.1.19SECTION 880.5400
   880.5400 Neonatal incubator.
21:8.0.1.1.27.5.1.20SECTION 880.5410
   880.5410 Neonatal transport incubator.
21:8.0.1.1.27.5.1.21SECTION 880.5420
   880.5420 Pressure infusor for an I.V. bag.
21:8.0.1.1.27.5.1.22SECTION 880.5430
   880.5430 Nonelectrically powered fluid injector.
21:8.0.1.1.27.5.1.23SECTION 880.5440
   880.5440 Intravascular administration set.
21:8.0.1.1.27.5.1.24SECTION 880.5445
   880.5445 Intravascular administration set, automated air removal system.
21:8.0.1.1.27.5.1.25SECTION 880.5450
   880.5450 Patient care reverse isolation chamber.
21:8.0.1.1.27.5.1.26SECTION 880.5475
   880.5475 Jet lavage.
21:8.0.1.1.27.5.1.27SECTION 880.5500
   880.5500 AC-powered patient lift.
21:8.0.1.1.27.5.1.28SECTION 880.5510
   880.5510 Non-AC-powered patient lift.
21:8.0.1.1.27.5.1.29SECTION 880.5550
   880.5550 Alternating pressure air flotation mattress.
21:8.0.1.1.27.5.1.30SECTION 880.5560
   880.5560 Temperature regulated water mattress.
21:8.0.1.1.27.5.1.31SECTION 880.5570
   880.5570 Hypodermic single lumen needle.
21:8.0.1.1.27.5.1.32SECTION 880.5580
   880.5580 Acupuncture needle.
21:8.0.1.1.27.5.1.33SECTION 880.5630
   880.5630 Nipple shield.
21:8.0.1.1.27.5.1.34SECTION 880.5640
   880.5640 Lamb feeding nipple.
21:8.0.1.1.27.5.1.35SECTION 880.5680
   880.5680 Pediatric position holder.
21:8.0.1.1.27.5.1.36SECTION 880.5700
   880.5700 Neonatal phototherapy unit.
21:8.0.1.1.27.5.1.37SECTION 880.5725
   880.5725 Infusion pump.
21:8.0.1.1.27.5.1.38SECTION 880.5740
   880.5740 Suction snakebite kit.
21:8.0.1.1.27.5.1.39SECTION 880.5760
   880.5760 Chemical cold pack snakebite kit.
21:8.0.1.1.27.5.1.40SECTION 880.5780
   880.5780 Medical support stocking.
21:8.0.1.1.27.5.1.41SECTION 880.5820
   880.5820 Therapeutic scrotal support.
21:8.0.1.1.27.5.1.42SECTION 880.5860
   880.5860 Piston syringe.
21:8.0.1.1.27.5.1.43SECTION 880.5950
   880.5950 Umbilical occlusion device.
21:8.0.1.1.27.5.1.44SECTION 880.5960
   880.5960 Lice removal kit.
21:8.0.1.1.27.5.1.45SECTION 880.5965
   880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
21:8.0.1.1.27.5.1.46SECTION 880.5970
   880.5970 Percutaneous, implanted, long-term intravascular catheter.
21:8.0.1.1.27.6SUBPART G
Subpart G - General Hospital and Personal Use Miscellaneous Devices
21:8.0.1.1.27.6.1.1SECTION 880.6025
   880.6025 Absorbent tipped applicator.
21:8.0.1.1.27.6.1.2SECTION 880.6050
   880.6050 Ice bag.
21:8.0.1.1.27.6.1.3SECTION 880.6060
   880.6060 Medical disposable bedding.
21:8.0.1.1.27.6.1.4SECTION 880.6070
   880.6070 Bed board.
21:8.0.1.1.27.6.1.5SECTION 880.6080
   880.6080 Cardiopulmonary resuscitation board.
21:8.0.1.1.27.6.1.6SECTION 880.6085
   880.6085 Hot/cold water bottle.
21:8.0.1.1.27.6.1.7SECTION 880.6100
   880.6100 Ethylene oxide gas aerator cabinet.
21:8.0.1.1.27.6.1.8SECTION 880.6140
   880.6140 Medical chair and table.
21:8.0.1.1.27.6.1.9SECTION 880.6150
   880.6150 Ultrasonic cleaner for medical instruments.
21:8.0.1.1.27.6.1.10SECTION 880.6175
   880.6175 [Reserved]
21:8.0.1.1.27.6.1.11SECTION 880.6185
   880.6185 Cast cover.
21:8.0.1.1.27.6.1.12SECTION 880.6190
   880.6190 Mattress cover for medical purposes.
21:8.0.1.1.27.6.1.13SECTION 880.6200
   880.6200 Ring cutter.
21:8.0.1.1.27.6.1.14SECTION 880.6210
   880.6210 Sharps needle destruction device.
21:8.0.1.1.27.6.1.15SECTION 880.6230
   880.6230 Tongue depressor.
21:8.0.1.1.27.6.1.16SECTION 880.6250
   880.6250 Non-powdered patient examination glove.
21:8.0.1.1.27.6.1.17SECTION 880.6260
   880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
21:8.0.1.1.27.6.1.18SECTION 880.6265
   880.6265 Examination gown.
21:8.0.1.1.27.6.1.19SECTION 880.6280
   880.6280 Medical insole.
21:8.0.1.1.27.6.1.20SECTION 880.6300
   880.6300 Implantable radiofrequency transponder system for patient identification and health information.
21:8.0.1.1.27.6.1.21SECTION 880.6305
   880.6305 Ingestible event marker.
21:8.0.1.1.27.6.1.22SECTION 880.6310
   880.6310 Medical device data system.
21:8.0.1.1.27.6.1.23SECTION 880.6315
   880.6315 Remote Medication Management System.
21:8.0.1.1.27.6.1.24SECTION 880.6320
   880.6320 AC-powered medical examination light.
21:8.0.1.1.27.6.1.25SECTION 880.6350
   880.6350 Battery-powered medical examination light.
21:8.0.1.1.27.6.1.26SECTION 880.6375
   880.6375 Patient lubricant.
21:8.0.1.1.27.6.1.27SECTION 880.6430
   880.6430 Liquid medication dispenser.
21:8.0.1.1.27.6.1.28SECTION 880.6450
   880.6450 Skin pressure protectors.
21:8.0.1.1.27.6.1.29SECTION 880.6500
   880.6500 Medical ultraviolet air purifier.
21:8.0.1.1.27.6.1.30SECTION 880.6600
   880.6600 Ultraviolet (UV) radiation chamber disinfection device.
21:8.0.1.1.27.6.1.31SECTION 880.6710
   880.6710 Medical ultraviolet water purifier.
21:8.0.1.1.27.6.1.32SECTION 880.6730
   880.6730 Body waste receptacle.
21:8.0.1.1.27.6.1.33SECTION 880.6740
   880.6740 Vacuum-powered body fluid suction apparatus.
21:8.0.1.1.27.6.1.34SECTION 880.6760
   880.6760 Protective restraint.
21:8.0.1.1.27.6.1.35SECTION 880.6775
   880.6775 Powered patient transfer device.
21:8.0.1.1.27.6.1.36SECTION 880.6785
   880.6785 Manual patient transfer device.
21:8.0.1.1.27.6.1.37SECTION 880.6800
   880.6800 Washers for body waste receptacles.
21:8.0.1.1.27.6.1.38SECTION 880.6820
   880.6820 Medical disposable scissors.
21:8.0.1.1.27.6.1.39SECTION 880.6850
   880.6850 Sterilization wrap.
21:8.0.1.1.27.6.1.40SECTION 880.6860
   880.6860 Ethylene oxide gas sterilizer.
21:8.0.1.1.27.6.1.41SECTION 880.6870
   880.6870 Dry-heat sterilizer.
21:8.0.1.1.27.6.1.42SECTION 880.6880
   880.6880 Steam sterilizer.
21:8.0.1.1.27.6.1.43SECTION 880.6885
   880.6885 Liquid chemical sterilants/high level disinfectants.
21:8.0.1.1.27.6.1.44SECTION 880.6890
   880.6890 General purpose disinfectants.
21:8.0.1.1.27.6.1.45SECTION 880.6900
   880.6900 Hand-carried stretcher.
21:8.0.1.1.27.6.1.46SECTION 880.6910
   880.6910 Wheeled stretcher.
21:8.0.1.1.27.6.1.47SECTION 880.6920
   880.6920 Syringe needle introducer.
21:8.0.1.1.27.6.1.48SECTION 880.6960
   880.6960 Irrigating syringe.
21:8.0.1.1.27.6.1.49SECTION 880.6970
   880.6970 Liquid crystal vein locator.
21:8.0.1.1.27.6.1.50SECTION 880.6980
   880.6980 Vein stabilizer.
21:8.0.1.1.27.6.1.51SECTION 880.6990
   880.6990 Infusion stand.
21:8.0.1.1.27.6.1.52SECTION 880.6991
   880.6991 Medical washer.
21:8.0.1.1.27.6.1.53SECTION 880.6992
   880.6992 Medical washer-disinfector.