(a) An alert system will be set up during the transition period and maintained thereafter by which the parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an appendix F of this subpart. As part of that system, each party shall notify the other party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations.
(b) Contact points will be agreed between both parties to permit authorities to be made aware with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.
Sec. Appendix A to Subpart B of Part 26--Relevant Legislation,
Regulations, and Procedures. 1. For the European Community (EC) the following legislation applies to
Sec. 26.42(a) of this subpart:
[Copies of EC documents may be obtained from the European Document Research, 1100 17th St. NW., suite 301, Washington, DC 20036.]a. Council Directive 90/385/EEC of 20 June 1990 on active implantable medical devices
OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment procedures.
Annex 2 (with the exception of section 4)
Annex 4
Annex 5b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ No. L 169,12.7.1993, p.1. Conformity assessment procedures.
Annex 2 (with the exception of section 4)
Annex 3
Annex 4
Annex 5
Annex 6
2. For the United States, the following legislation applies to Sec.
26.32(a):
[Copies of FDA documents may be obtained from the Government Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents may be viewed on FDA's Internet web site at http://www.fda.gov.]a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.b. The Public Health Service Act, 42 U.S.C. 201 et seq.c. Regulations of the United States Food and Drug Administration found at 21 CFR, in particular, Parts 800 to 1299.d. Medical Devices; Third Party Review of Selected Premarket Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).e. Draft Guidance Document on Accredited Persons Program, 63 FR 28392 (May 22, 1998).f. Draft Guidance for Staff, Industry and Third Parties, Third Party Programs under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA), 63 FR 36240 (July 2, 1998).g. Guidance Document on Use of Standards, 63 FR 9561 (February 25, 1998).
Sec. Appendix B to Subpart B of Part 26--Scope of Product Coverage
1. Initial Coverage of the Transition Period Upon entry into force of this subpart as described in Sec. 26.80 (it is understood that the date of entry into force will not occur prior to June 1, 1998, unless the parties decide otherwise), products qualifying for the transitional arrangements under this subpart include:
a. All Class I products requiring premarket evaluations in the United States--see Table 1.
b. Those Class II products listed in Table 2.
2. During the Transition Period The parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows:
a. Those for which review may be based primarily on written guidance which the parties will use their best efforts to prepare expeditiously; and
b. Those for which review may be based primarily on international standards, in order for the parties to gain the requisite experience.The corresponding additional product lists will be phased in on an annual basis. The parties may consult with industry and other interested parties in determining which products will be added.
3. Commencement of the Operational Period
a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period.
b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third party review is available in the United States.
4. Unless explicitly included by joint decision of the parties, this
part does not cover any U.S. Class II-tier 3 or any Class III product
under either system.
[The lists of medical devices included in these tables are subject to change as a result of the Food and Drug Administration Modernization Act of 1997.]
Table 1--Class I Products Requiring Premarket Evaluations in the UnitedStates, Included in Scope of Product Coverage at Beginning of Transition
Period \1\------------------------------------------------------------------------
21 CFR Section No. Regulation Name------------------------------------------------------------------------
Product Code--Device Name------------------------------------------------------------------------Anesthesiology Panel (21 CFR
part 868)
868.1910................. Esophageal Stethoscope
BZW--Stethoscope, Esophageal
868.5620................. Breathing Mouthpiece
BYP--Mouthpiece, Breathing
868.5640................. Medicinal Nonventilatory Nebulizer
(Atomizer)
CCQ--Nebulizer, Medicinal, Nonventilatory
(Atomizer)
868.5675................. Rebreathing Device
BYW--Device, Rebreathing
868.5700................. Nonpowered Oxygen Tent
FOG--Hood, Oxygen, Infant
BYL--Tent, Oxygen
868.6810................. Tracheobronchial Suction Catheter
BSY--Catheters, Suction, TracheobronchialCardiovascular Panel
(None)...................Dental Panel (21 CFR part
872)
872.3400................. Karaya and Sodium Borate With or Without
Acacia Denture Adhesive
KOM--Adhesive, Denture, Acacia and Karaya
With Sodium Borate
872.3700................. Dental Mercury (U.S.P.)
ELY--Mercury
872.4200................. Dental Handpiece and Accessories
EBW--Controller, Food, Handpiece and Cord
EFB--Handpiece, Air-Powered, Dental
EFA--Handpiece, Belt and/or Gear Driven,
Dental
EGS--Handpiece, Contra- and Right-Angle
Attachment, Dental
EKX--Handpiece, Direct Drive, AC-Powered
EKY--Handpiece, Water-Powered
872.6640................. Dental Operative Unit and Accessories
EIA--Unit, Operative DentalEar, Nose, and Throat Panel
(21 CFR Part 874)
874.1070................. Short Increment Sensitivity Index (SISI)
Adapter
ETR--Adapter, Short Increment Sensitivity
Index (SISI)
874.1500................. Gustometer
ETM--Gustometer
874.1800................. Air or Water Caloric Stimulator
KHH--Stimulator, Caloric-Air
ETP--Stimulator, Caloric-Water
874.1925................. Toynbee Diagnostic Tube
ETK--Tube, Toynbee Diagnostic
874.3300................. Hearing Aid
LRB--Face Plate Hearing-Aid
ESD--Hearing-aid, Air-Conduction
874.4100................. Epistaxis Balloon
EMX--Balloon, Epistaxis
874.5300................. ENT Examination and Treatment Unit
ETF--Unit, Examining/Treatment, ENT
874.5550................. Powered Nasal Irrigator
KMA--Irrigator, Powered Nasal
874.5840................. Antistammering Device
KTH--Device, Anti-StammeringGastroenterology--Urology
Panel (21 CFR Part 876)
876.5160................. Urological Clamp for Males
FHA--Clamp, Penile
876.5210................. Enema Kit
FCE--Kit, Enema, (for Cleaning Purpose)
876.5250................. Urine Collector and Accessories
FAQ--Bag, Urine Collection, Leg, for
External UseGeneral Hospital Panel (21
CFR Part 880)
880.5270................. Neonatal Eye Pad
FOK--Pad, Neonatal Eye
880.5420................. Pressure Infusor for an I.V. Bag
KZD--Infusor, Pressure, for I.V. Bags
880.5680................. Pediatric Position Holder
FRP--Holder, Infant Position
880.6250................. Patient Examination Glove
LZB--Finger Cot
FMC--Glove, Patient Examination
LYY--Glove, Patient Examination, Latex
LZA--Glove, Patient Examination, Poly
LZC--Glove, Patient Examination,
Speciality
LYZ--Glove, Patient Examination, Vinyl
880.6375................. Patient Lubricant
KMJ--Lubricant, Patient
880.6760................. Protective Restraint
BRT--Restraint, Patient, Conductive
FMQ--Restraint, ProtectiveNeurology Panel (21 CFR Part
882)
882.1030................. Ataxiagraph
GWW--Ataxiagraph
882.1420................. Electroencephalogram (EEG) Signal
Spectrum Analyzer
GWS--Analyzer, Spectrum,
Electroencephalogram Signal
882.4060................. Ventricular Cannula
HCD--Cannula, Ventricular
882.4545................. Shunt System Implantation Instrument
GYK--Instrument, Shunt System
Implantation
882.4650................. Neurosurgical Suture Needle
HAS--Needle, Neurosurgical Suture
882.4750................. Skull Punch
GXJ--Punch, SkullObstetrics and Gynecology
Panel
(None)...................Ophthalmology Panel (21 CFR
Part 886)
886.1780................. Retinoscope
HKM--Retinoscope, Battery-Powered
886.1940................. Tonometer Sterilizer
HKZ--Sterilizer, Tonometer
886.4070................. Powered Corneal Burr
HQS--Burr, Corneal, AC-Powered
HOG--Burr, Corneal, Battery-Powered
HRG--Engine, Trephine, Accessories, AC-
Powered
HFR--Engine, Trephine, Accessories,
Battery-Powered
HLD--Engine, Trephine, Accessories, Gas-
Powered
886.4370................. Keratome
HNO--Keratome, AC-Powered
HMY--Keratome, Battery-Powered
886.5850................. Sunglasses (Nonprescription)
HQY--Sunglasses (Nonprescription
Including Photosensitive)Orthopedic Panel (21 CFR Part
888)
888.1500................. Goniometer
KQX--Goniometer, AC-Powered
888.4150................. Calipers for Clinical Use
KTZ--CaliperPhysical Medicine Panel (21
CFR Part 890)
890.3850................. Mechanical Wheelchair
LBE--Stroller, Adaptive
IOR--Wheelchair, Mechanical
890.5180................. Manual Patient Rotation Bed
INY--Bed, Patient Rotation, Manual
890.5710................. Hot or Cold Disposable Pack
IMD--Pack, Hot or Cold, DisposableRadiology Panel (21 CFR Part
892)
892.1100................. Scintillation (Gamma) Camera
IYX--Camera, Scintillation (Gamma)
892.1110................. Positron Camera
IZC--Camera, Positron
892.1300................. Nuclear Rectilinear Scanner
IYW--Scanner, Rectilinear, Nuclear
892.1320................. Nuclear Uptake Probe
IZD--Probe, Uptake, Nuclear
892.1330................. Nuclear Whole Body Scanner
JAM--Scanner, Whole Body, Nuclear
892.1410................. Nuclear Electrocardiograph Synchronizer
IVY--Synchronizer, Electrocardiograph,
Nuclear
892.1890................. Radiographic Film Illuminator
IXC--Illuminator, Radiographic-Film
JAG--Illuminator, Radiographic-Film,
Explosion-Proof
892.1910................. Radiographic Grid
IXJ--Grid, Radiographic
892.1960................. Radiographic Intensifying Screen
EAM--Screen, Intensifying, Radiographic
892.1970................. Radiographic ECG/Respirator Synchronizer
IXO--Synchronizer, ECG/Respirator,
Radiographic
892.5650................. Manual Radionuclide Applicator System
IWG--System, Applicator, Radionuclide,
ManualGeneral and Plastic Surgery
Panel (21 CFR Part 878)
878.4200................. Introduction/Drainage Catheter and
Accessories
KGZ--Accessories, Catheter
GCE--Adaptor, Catheter
FGY--Cannula, Injection
GBA--Catheter, Balloon Type
GBZ--Catheter, Cholangiography
GBQ--Catheter, Continuous Irrigation
GBY--Catheter, Eustachian, General &
Plastic Surgery
JCY--Catheter, Infusion
GBX--Catheter, Irrigation
GBP--Catheter, Multiple Lumen
GBO--Catheter, Nephrostomy, General &
Plastic Surgery
GBN--Catheter, Pediatric, General &
Plastic Surgery
GBW--Catheter, Peritoneal
GBS--Catheter, Ventricular, General &
Plastic Surgery
GCD--Connector, Catheter
GCC--Dilator, Catheter
GCB--Needle, Catheter
878.4320................. Removable Skin Clip
FZQ--Clip, Removable (Skin)
878.4460................. Surgeon's Gloves
KGO--Surgeon's Gloves
878.4680................. Nonpowered, Single Patient, Portable
Suction Apparatus
GCY--Apparatus, Suction, Single Patient
Use, Portable, Nonpowered
878.4760................. Removable Skin Staple
GDT--Staple, Removable (Skin)
878.4820................. AC-Powered, Battery-Powered, and
Pneumatically Powered Surgical
Instrument Motors and Accessories/
Attachments
GFG--Bit, Surgical
GFA--Blade, Saw, General & Plastic
Surgery
DWH--Blade, Saw, Surgical, Cardiovascular
BRZ--Board, Arm (With Cover)
GFE--Brush, Dermabrasion
GFF--Bur, Surgical, General & Plastic
Surgery
KDG--Chisel (Osteotome)
GFD--Dermatome
GFC--Driver, Surgical, Pin
GFB--Head, Surgical, Hammer
GEY--Motor, Surgical Instrument, AC-
Powered
GET--Motor, Surgical Instrument,
Pneumatic Powered
DWI--Saw, Electrically Powered
KFK--Saw, Pneumatically Powered
HAB--Saw, Powered, and Accessories
878.4960................. Air or AC-Powered Operating Table and Air
or AC-Powered Operating Chair &
Accessories
GBB--Chair, Surgical, AC-Powered
FQO--Table, Operating-Room, AC-Powered
GDC--Table, Operating-Room, Electrical
FWW--Table, Operating-Room, Pneumatic
JEA--Table, Surgical with Orthopedic
Accessories, AC-Powered
880.5090................. Liquid Bandage
KMF--Bandage, Liquid------------------------------------------------------------------------\1\Descriptive information on product codes, panel codes, and other
medical device identifiers may be viewed on FDA's Internet Web Site at
http://www.fda.gov/cdrh/prodcode.html.
Table 2--Class II Medical Devices Included in Scope of Product Coverage
at Beginning of Transition Period (United States to develop guidance
documents identifying U.S. requirements and European Community (EC) to
identify standards needed to meet EC requirements) \1\------------------------------------------------------------------------
Panel 21 CFR Section Regulation Name------------------------------- No. ----------------------
------------------- Product Code--Device
Name------------------------------------------------------------------------
RA........................ 892.1000......... Magnetic Resonance
Diagnostic Device
MOS--COIL, Magnetic
Resonance, Specialty
LNH--System, Nuclear
Magnetic Resonance
Imaging
LNI--System, Nuclear
Magnetic Resonance
SpectroscopicDiagnostic Ultrasound:
RA........................ 892.1540......... Nonfetal Ultrasonic
Monitor
JAF--Monitor,
Ultrasonic, Nonfetal
RA........................ 892.1550......... Ultrasonic Pulsed
Doppler Imaging
System
IYN--System, Imaging,
Pulsed Doppler,
Ultrasonic
RA........................ 892.1560......... Ultrasonic Pulsed
Echo Imaging System
IYO--System, Imaging,
Pulsed Echo,
Ultrasonic
RA........................ 892.1570......... Diagnostic Ultrasonic
Transducer
ITX--Transducer,
Ultrasonic,
DiagnosticDiagnostic X-Ray Imaging
Devices (except mammographic
x-ray systems):
RA........................ 892.1600......... Angiographic X-Ray
System
IZI--System, X-Ray,
Angiographic
RA........................ 892.1650......... Image-Intensified
Fluoroscopic X-Ray
System
MQB--Solid State X-
Ray Imager (Flat
Panel/Digital
Imager)
JAA--System, X-Ray,
Fluoroscopic, Image-
Intensified
RA........................ 892.1680......... Stationary X-Ray
System
KPR--System, X-Ray,
Stationary
RA........................ 892.1720......... Mobile X-Ray System
IZL--System, X-Ray,
Mobile
RA........................ 892.1740......... Tomographic X-Ray
System
IZF--System, X-Ray,
Tomographic
RA........................ 892.1750......... Computed Tomography X-
Ray System
JAK--System, X-Ray,
Tomography, ComputedECG-Related Devices:
CV........................ 870.2340......... Electrocardiograph
DPS--Electrocardiogra
ph
MLC--Monitor, ST
Segment
CV........................ 870.2350......... Electrocardiograph
Lead Switching
Adaptor
DRW--Adaptor, Lead
Switching,
Electrocardiograph
CV........................ 870.2360......... Electrocardiograph
Electrode
DRX--Electrode,
Electrocardiograph
CV........................ 870.2370......... Electrocardiograph
Surface Electrode
Tester
KRC--Tester,
Electrode, Surface,
Electrocardiographic
NE........................ 882.1400......... Electroencephalograph
GWQ--Electroencephalo
graph
HO........................ 880.5725......... Infusion Pump
(external only)
MRZ--Accessories,
Pump, Infusion
FRN--Pump, Infusion
LZF--Pump, Infusion,
Analytical Sampling
MEB--Pump, Infusion,
Elastomeric
LZH--Pump, Infusion,
Enteral
MHD--Pump, Infusion,
Gallstone
Dissolution
LZG--Pump, Infusion,
Insulin
MEA--Pump, Infusion,
PCAOphthalmic Instruments:
OP........................ 886.1570......... Ophthalmoscope
HLI--Ophthalmoscope,
AC-Powered
HLJ--Ophthalmoscope,
Battery-Powered
OP........................ 886.1780......... Retinoscope
HKL--Retinoscope, AC-
Powered
OP........................ 886.1850......... AC-Powered Slit-Lamp
Biomicroscope
HJO--Biomicroscope,
Slit-Lamp, AC-
Powered
OP........................ 886.4150......... Vitreous Aspiration
and Cutting
Instrument
MMC--Dilator,
Expansive Iris
(Accessory)
HQE--Instrument,
Vitreous Aspiration
and Cutting, AC-
Powered
HKP--Instrument,
Vitreous Aspiration
and Cutting, Battery-
Powered
MLZ--Vitrectomy,
Instrument Cutter
OP........................ 886.4670......... Phacofragmentation
System
HQC--Unit,
Phacofragmentation
SU........................ 878.4580......... Surgical Lamp
HBI--Illuminator,
Fiberoptic, Surgical
Field
FTF--Illuminator,
Nonremote
FTG--Illuminator,
Remote
HJE--Lamp,
Fluorescein, AC-
Powered
FQP--Lamp, Operating-
Room
FTD--Lamp, Surgical
GBC--Lamp, Surgical,
Incandescent
FTA--Light, Surgical,
Accessories
FSZ--Light, Surgical,
Carrier
FSY--Light, Surgical,
Ceiling Mounted
FSX--Light, Surgical,
Connector
FSW--Light, Surgical,
Endoscopic
FST--Light, Surgical,
Fiberoptic
FSS--Light, Surgical,
Floor Standing
FSQ--Light, Surgical,
Instrument
NE........................ 882.5890......... Transcutaneous
Electrical Nerve
Stimulator for Pain
Relief
GZJ--Stimulator,
Nerve,
Transcutaneous, For
Pain Relief
Noninvasive Blood
Pressure Measurement
Devices:
CV........................ 870.1120......... Blood Pressure Cuff
DXQ--Cuff, Blood-
Pressure
CV........................ 870.1130......... Noninvasive Blood
Pressure Measurement
System (except
nonoscillometric)
DXN--System,
Measurement, Blood-
Pressure,
Noninvasive
HO........................ 880.6880......... Steam Sterilizer
(greater than 2
cubic feet)
FLE--Sterilizer,
SteamClinical Thermometers:
HO........................ 880.2910......... Clinical Electronic
Thermometer (except
tympanic or
pacifier)
FLL--Thermometer,
Electronic, Clinical
AN........................ 868.5630......... Nebulizer
CAF--Nebulizer
(Direct Patient
Interface)Hypodermic Needles and
Syringes (except antistick
and self-destruct):
HO........................ 880.5570......... Hypodermic Single
Lumen Needle
MMK--Container,
Sharpes
FMI--Needle,
Hypodermic, Single
Lumen
MHC--Port,
Intraosseous,
Implanted
HO........................ 880.5860......... Piston Syringe
FMF--Syringe, PistonSelected Dental Materials:
DE........................ 872.3060......... Gold-Based Alloys and
Precious Metal
Alloys for Clinical
Use
EJT--Alloy, Gold
Based, For Clinical
Use
EJS--Alloy, Precious
Metal, For Clinical
Use
DE........................ 872.3200......... Resin Tooth Bonding
Agent
KLE--Agent, Tooth
Bonding, Resin
DE........................ 872.3275......... Dental Cement
EMA--Cement, Dental
EMB--Zinc Oxide
Eugenol
DE........................ 872.3660......... Impression Material
ELW--Material,
Impression
DE........................ 872.3690......... Tooth Shade Resin
Material
EBF--Material, Tooth
Shade, Resin
DE........................ 872.3710......... Base Metal Alloy
EJH--Metal, BaseLatex Condoms:
OB........................ 884.5300......... Condom
HIS--Condom------------------------------------------------------------------------\1\Descriptive information on product codes, panel codes, and other
medical device identifiers may be viewed on FDA's Internet Web Site at
http://www.fda.gov/cdrh/prodcode.html.
Table 3--Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period \1\----------------------------------------------------------------------------------------------------------------
Product Family 21 CFR Section No Device Name Tier----------------------------------------------------------------------------------------------------------------Anesthesiology Panel
Anesthesia Devices................ 868.5160............... Gas machine for 2
anesthesia or analgesia.
868.5270............... Breathing system heater.. 2
868.5440............... Portable oxygen generator 2
868.5450............... Respiratory gas 2
humidifier.
868.5630............... Nebulizer................ 2
868.5710............... Electrically powered 2
oxygen tent.
868.5880............... Anesthetic vaporizer..... 2
Gas Analyser...................... 868.1040............... Powered Algesimeter...... 2
868.1075............... Argon gas analyzer....... 2
868.1400............... Carbon dioxide gas 2
analyzer.
868.1430............... Carbon monoxide gas 2
analyzer.
868.1500............... Enflurane gas analyzer... 2
868.1620............... Halothane gas analyzer... 2
868.1640............... Helium gas analyzer...... 2
868.1670............... Neon gas analyzer........ 2
868.1690............... Nitrogen gas analyzer.... 2
868.1700............... Nitrous oxide gas 2
analyzer.
868.1720............... Oxygen gas analyzer...... 2
868.1730............... Oxygen uptake computer... 2
Peripheral Nerve Stimulators...... 868.2775............... Electrical peripheral 2
nerve stimulator.
Respiratory Monitoring............ 868.1750............... Pressure plethysmograph.. 2
868.1760............... Volume plethysmograph.... 2
868.1780............... Inspiratory airway 2
pressure meter.
868.1800............... Rhinoanemometer.......... 2
868.1840............... Diagnostic spirometer.... 2
868.1850............... Monitoring spirometer.... 2
868.1860............... Peak-flow meter for 2
spirometry.
868.1880............... Pulmonary-function data 2
calculator.
868.1890............... Predictive pulmonary- 2
function value
calculator.
868.1900............... Diagnostic pulmonary- 2
function interpretation
calculator.
868.2025............... Ultrasonic air embolism 2
monitor.
868.2375............... Breathing frequency 2
monitor (except apnea
detectors).
868.2480............... Cutaneous carbon dioxide 2
(PcCO2) monitor.
868.2500............... Cutaneous oxygen monitor 2
(for an infant not under
gas anesthesia).
868.2550............... Pneumotachomometer....... 2
868.2600............... Airway pressure monitor.. 2
868.5665............... Powered percussor........ 2
868.5690............... Incentive spirometer..... 2
Ventilator........................ 868.5905............... Noncontinuous ventilator 2
(IPPB).
868.5925............... Powered emergency 2
ventilator.
868.5935............... External negative 2
pressure ventilator.
868.5895............... Continuous ventilator.... 2
868.5955............... Intermittent mandatory 2
ventilation attachment.
868.6250............... Portable air compressor.. 2Cardiovascular Panel
Cardiovascular Diagnostic......... 870.1425............... Programmable diagnostic 2
computer.
870.1450............... Densitometer............. 2
870.2310............... Apex cardiograph 2
(vibrocardiograph).
870.2320............... Ballistocardiograph...... 2
870.2340............... Electrocardiograph....... 2
870.2350............... Electrocardiograph lead 1
switching adaptor.
870.2360............... Electrocardiograph 2
electrode.
870.2370............... Electrocardiograph 2
surface electrode tester.
870.2400............... Vectorcardiograph........ 1
870.2450............... Medical cathode-ray tube 1
display.
870.2675............... Oscillometer............. 2
870.2840............... Apex cardiographic 2
transducer.
870.2860............... Heart sound transducer... 2
Cardiovascular Monitoring......... ....................... Valve, pressure relief,
cardiopulmonary bypass.
870.1100............... Blood pressure alarm..... 2
870.1110............... Blood pressure computer.. 2
870.1120............... Blood pressure cuff...... 2
870.1130............... Noninvasive blood 2
pressure measurement
system.
870.1140............... Venous blood pressure 2
manometer.
870.1220............... Electrode recording 2
catheter or electrode
recording probe.
870.1270............... Intracavitary 2
phonocatheter system.
870.1875............... Stethoscope (electronic). 2
870.2050............... Biopotential amplifier 2
and signal conditioner.
870.2060............... Transducer signal 2
amplifier and
conditioner.
870.2100............... Cardiovascular blood flow- 2
meter.
870.2120............... Extravascular blood flow 2
probe.
870.2300............... Cardiac monitor 2
(including
cardiotachometer and
rate alarm).
870.2700............... Oximeter................. 2
870.2710............... Ear oximeter............. 2
870.2750............... Impedance phlebograph.... 2
870.2770............... Impedance plethysmograph. 2
870.2780............... Hydraulic, pneumatic, or 2
photoelectric
plethysmographs.
870.2850............... Extravascular blood 2
pressure transducer.
870.2870............... Catheter tip pressure 2
transducer.
870.2880............... Ultrasonic transducer.... 2
870.2890............... Vessel occlusion 2
transducer.
870.2900............... Patient transducer and 2
electrode cable
(including connector).
870.2910............... Radiofrequency 2
physiological signal
transmitter and receiver.
870.2920............... Telephone 2
electrocardiograph
transmitter and receiver.
870.4205............... Cardiopulmonary bypass 2
bubble detector.
870.4220............... Cardiopulmonary bypass 2
heart-lung machine
console.
870.4240............... Cardiovascular bypass 2
heat exchanger.
870.4250............... Cardiopulmonary bypass 2
temperature controller.
870.4300............... Cardiopulmonary bypass 2
gas control unit.
870.4310............... Cardiopulmonary bypass 2
coronary pressure gauge.
870.4330............... Cardiopulmonary bypass on- 2
line blood gas monitor.
870.4340............... Cardiopulmonary bypass 2
level sensing monitor
and/or control.
870.4370............... Roller-type 2
cardiopulmonary bypass
blood pump.
870.4380............... Cardiopulmonary bypass 2
pump speed control.
870.4410............... Cardiopulmonary bypass in- 2
line blood gas sensor.
Cardiovascular Therapeutic........ 870.5050............... Patient care suction 2
apparatus.
870.5900............... Thermal regulation system 2
Defibrillator..................... 870.5300............... DC-defibrillator 2
(including paddles).
870.5325............... Defibrillator tester..... 2
Echocardiograph................... 870.2330............... Echocardiograph.......... 2
Pacemaker & Accessories........... 870.1750............... External programmable 2
pacemaker pulse
generator.
870.3630............... Pacemaker generator 2
function analyzer.
870.3640............... Indirect pacemaker 2
generator function
analyzer.
870.3720............... Pacemaker electrode 2
function tester.
Miscellaneous..................... 870.1800............... Withdrawal-infusion pump. 2
870.2800............... Medical magnetic tape 2
recorder.
None................... Batteries, rechargeable,
class II devices.Dental Panel
Dental Equipment.................. 872.1720............... Pulp tester.............. 2
872.1740............... Caries detection device.. 2
872.4120............... Bone cutting instrument 2
and accessories.
872.4465............... Gas-powered jet injector. 2
872.4475............... Spring-powered jet 2
injector.
872.4600............... Intraoral ligature and 2
wire lock.
872.4840............... Rotary scaler............ 2
872.4850............... Ultrasonic scaler........ 2
872.4920............... Dental electrosurgical 2
unit and accessories.
872.6070............... Ultraviolet activator for 2
polymerization.
872.6350............... Ultraviolet detector..... 2
Dental Material................... 872.3050............... Amalgam alloy............ 2
872.3060............... Gold-based alloys and 2
precious metal alloys
for clinical use.
872.3200............... Resin tooth bonding agent 2
872.3250............... Calcium hydroxide cavity 2
liner.
872.3260............... Cavity varnish........... 2
872.3275............... Dental cement (other than 2
zinc oxide-eugenol).
872.3300............... Hydrophilic resin coating 2
for dentures.
872.3310............... Coating material for 2
resin fillings.
872.3590............... Preformed plastic denture 2
tooth.
872.3660............... Impression material...... 2
872.3690............... Tooth shade resin 2
material.
872.3710............... Base metal alloy......... 2
872.3750............... Bracket adhesive resin 2
and tooth conditioner.
872.3760............... Denture relining, 2
repairing, or rebasing
resin.
872.3765............... Pit and fissure sealant 2
and conditioner.
872.3770............... Temporary crown and 2
bridge resin.
872.3820............... Root canal filling resin 2
(other than chloroform
use).
872.3920............... Porcelain tooth.......... 2
Dental X-ray...................... 872.1800............... Extraoral source x-ray 2
system.
872.1810............... Intraoral source x-ray 2
system.
Dental Implants................... 872.4880............... Intraosseous fixation 2
screw or wire.
872.3890............... Endodontic stabilizing 2
splint.
Orthodontic....................... 872.5470............... Orthodontic plastic 2
bracket.Ear/Nose/Throat Panel
Diagnostic Equipment.............. 874.1050............... Audiometer............... 2
874.1090............... Auditory impedance tester 2
874.1120............... Electronic noise 2
generator for
audiometric testing.
874.1325............... Electroglottograph....... 2
874.1820............... Surgical nerve stimulator/ 2
locator.
Hearing Aids...................... 874.3300............... Hearing aid (for bone- 2
conduction).
874.3310............... Hearing aid calibrator 2
and analysis system.
874.3320............... Group hearing aid or 2
group auditory trainer.
874.3330............... Master hearing aid....... 2
Surgical Equipment................ 874.4250............... Ear, nose, and throat 1
electric or pneumatic
surgical drill.
874.4490............... Argon laser for otology, 2
rhinology, and
laryngology.
874.4500............... Ear, nose, and throat 2
microsurgical carbon
dioxide laser.Gastroenterology/Urology Panel
Endoscope (including angioscopes, 876.1500............... Endoscope and accessories 2
laparscopes, ophthalmic
endoscopes).
876.4300............... Endoscopic 2
electrosurgical unit and
accessories.
Gastroenterology.................. 876.1725............... Gastrointestinal motility 1
monitoring system.
Hemodialysis...................... 876.5600............... Sorbent regenerated 2
dialysate delivery
system for hemodialysis.
876.5630............... Peritoneal dialysis 2
system and accessories.
876.5665............... Water purification system 2
for hemodialysis.
876.5820............... Hemodialysis system and 2
accessories.
876.5830............... Hemodialyzer with 2
disposable insert (kiil-
type).
Lithotriptor...................... 876.4500............... Mechanical lithotriptor.. 2
Urology Equipment................. 876.1620............... Urodynamics measurement 2
system.
876.5320............... Nonimplanted electrical 2
continence device.
876.5880............... Isolated kidney perfusion 2
and transport system and
accessories.General Hospital Panel
Infusion Pumps and Systems........ 880.2420............... Electronic monitor for 2
gravity flow infusion
systems.
880.2460............... Electrically powered 2
spinal fluid pressure
monitor.
880.5430............... Nonelectrically powered 2
fluid injector.
880.5725............... Infusion pump............ 2
Neonatal Incubators............... 880.5400............... Neonatal incubator....... 2
880.5410............... Neonatal transport 2
incubator.
880.5700............... Neonatal phototherapy 2
unit.
Piston Syringes................... 880.5570............... Hypodermic single lumen 1
needle.
880.5860............... Piston syringe (except 1
antistick).
880.6920............... Syringe needle introducer 2
Miscellaneous..................... 880.2910............... Clinical electronic 2
thermometer.
880.2920............... Clinical mercury 2
thermometer.
880.5100............... AC-powered adjustable 1
hospital bed.
880.5500............... AC-powered patient lift.. 2
880.6880............... Steam sterilizer (greater 2
than 2 cubic feet).Neurology Panel
882.1020............... Rigidity analyzer........ 2
882.1610............... Alpha monitor............ 2
Neuro-Diagnostic.................. 882.1320............... Cutaneous electrode...... 2
882.1340............... Nasopharyngeal electrode. 2
882.1350............... Needle electrode......... 2
882.1400............... Electroencephalograph.... 2
882.1460............... Nystagmograph............ 2
882.1480............... Neurological endoscope... 2
882.1540............... Galvanic skin response 2
measurement device.
882.1550............... Nerve conduction velocity 2
measurement device.
882.1560............... Skin potential 2
measurement device.
882.1570............... Powered direct-contact 2
temperature measurement
device.
882.1620............... Intracranial pressure 2
monitoring device.
882.1835............... Physiological signal 2
amplifier.
882.1845............... Physiological signal 2
conditioner.
882.1855............... Electroencephalogram 2
(EEG) telemetry system.
882.5050............... Biofeedback device....... 2
Echoencephalography............... 882.1240............... Echoencephalograph....... 2
RPG............................... 882.4400............... Radiofrequency lesion 2
generator.
Neuro Surgery..................... none................... Electrode, spinal 2
epidural.
882.4305............... Powered compound cranial 2
drills, burrs,
trephines, and their
accessories.
882.4310............... Powered simple cranial 2
drills burrs, trephines,
and their accessories.
882.4360............... Electric cranial drill 2
motor.
882.4370............... Pneumatic cranial drill 2
motor.
882.4560............... Stereotaxic instrument... 2
882.4725............... Radiofrequency lesion 2
probe.
882.4845............... Powered rongeur.......... 2
882.5500............... Lesion temperature 2
monitor.
Stimulators....................... 882.1870............... Evoked response 2
electrical stimulator.
882.1880............... Evoked response 2
mechanical stimulator.
882.1890............... Evoked response photic 2
stimulator.
882.1900............... Evoked response auditory 2
stimulator.
882.1950............... Tremor transducer........ 2
882.5890............... Transcutaneous electrical 2
nerve stimulator for
pain relief.Obstetrics/Gynecology Panel
Fetal Monitoring.................. 884.1660............... Transcervical endoscope 2
(amnioscope) and
accessories.
884.1690............... Hysteroscope and 2
accessories (for
performance standards).
884.2225............... Obstetric-gynecologic 2
ultrasonic imager.
884.2600............... Fetal cardiac monitor.... 2
884.2640............... Fetal phonocardiographic 2
monitor and accessories.
884.2660............... Fetal ultrasonic monitor 2
and accessories.
884.2675............... Fetal scalp circular 1
(spiral) electrode and
applicator.
884.2700............... Intrauterine pressure 2
monitor and accessories.
884.2720............... External uterine 2
contraction monitor and
accessories.
884.2740............... Perinatal monitoring 2
system and accessories.
884.2960............... Obstetric ultrasonic 2
transducer and
accessories.
Gynecological Surgery Equipment... 884.1720............... Gynecologic laparoscope 2
and accessories.
884.4160............... Unipolar endoscopic 2
coagulator-cutter and
accessories.
884.4550............... Gynecologic surgical 2
laser.
884.4120............... Gynecologic 2
electrocautery and
accessories.
884.5300............... Condom................... 2
Ophthalmic Implants............... 886.3320............... Eye sphere implant....... 2
Contact Lens...................... 886.1385............... Polymethylmethacrylate 2
(PMMA) diagnostic
contact lens.
886.5916............... Rigid gas permeable 2
contact lens (daily wear
only).
Diagnostic Equipment.............. 886.1120............... Opthalmic camera......... 1
886.1220............... Corneal electrode........ 1
886.1250............... Euthyscope (AC-powered).. 1
886.1360............... Visual field laser 1
instrument.
886.1510............... Eye movement monitor..... 1
886.1570............... Ophthalmoscope........... 1
886.1630............... AC-powered 1
photostimulator.
886.1640............... Ophthalmic preamplifier.. 1
886.1670............... Ophthalmic isotope uptake 2
probe.
886.1780............... Retinoscope (AC-powered 1
device).
886.1850............... AC-powered slit lamp 1
biomicroscope.
886.1930............... Tonometer and accessories 2
886.1945............... Transilluminator (AC- 1
powered device).
886.3130............... Ophthalmic conformer..... 2
(Diagnostic/Surgery Equipment).... 886.4670............... Phacofragmentation system 2
Ophthalmic Implants............... 886.3340............... Extraocular orbital 2
implant.
886.3800............... Scleral shell............ 2
Surgical Equipment................ 880.5725............... Infusion pump 2
(performance standards).
886.3100............... Ophthalmic tantalum clip. 2
886.3300............... Absorbable implant 2
(scleral buckling
method).
886.4100............... Radiofrequency 2
electrosurgical cautery
apparatus.
886.4115............... Thermal cautery unit..... 2
886.4150............... Vitreous aspiration and 2
cutting instrument.
886.4170............... Cryophthalmic unit....... 2
886.4250............... Ophthalmic electrolysis 1
unit (AC-powered device).
886.4335............... Operating headlamp (AC- 1
powered device).
886.4390............... Ophthalmic laser......... 2
886.4392............... Nd:YAG laser for 2
posterior capsulotomy.
886.4400............... Electronic metal locator. 1
886.4440............... AC-powered magnet........ 1
886.4610............... Ocular pressure 2
applicator.
886.4690............... Ophthalmic 2
photocoagulator.
886.4790............... Ophthalmic sponge........ 2
886.5100............... Ophthalmic beta radiation 2
source.
none................... Ophthalmoscopes, 1
replacement batteries,
hand-held.Orthopedic Panel
Implants.......................... 888.3010............... Bone fixation cerclage... 2
888.3020............... Intramedullary fixation 2
rod.
888.3030............... Single/multiple component 2
metallic bone fixation
appliances and
accessories.
888.3040............... Smooth or threaded 2
metallic bone fixation
fastener.
888.3050............... Spinal interlaminal 2
fixation orthosis.
888.3060............... Spinal intervertebral 2
body fixation orthosis.
Surgical Equipment................ 888.1240............... AC-powered dynamometer... 2
888.4580............... Sonic surgical instrument 2
and accessories/
attachments.
none................... Accessories, fixation, 2
spinal interlaminal.
none................... Accessories, fixation, 2
spinal intervertebral
body.
none................... Monitor, pressure, 1
intracompartmental.
none................... Orthosis, fixation, 2
spinal intervertebral
fusion.
none................... Orthosis, spinal pedicle
fixation.
none................... System, cement removal 1
extraction.Physical Medicine Panel
Diagnostic Equipment or (Therapy) 890.1225............... Chronaximeter............ 2
Therapeutic Equipment.
890.1375............... Diagnostic 2
electromyograph.
890.1385............... Diagnostic 2
electromyograph needle
electrode.
890.1450............... Powered reflex hammer.... 2
890.1850............... Diagnostic muscle 2
stimulator.
or (Therapy)...................... 890.5850............... Powered muscle stimulator 2
Therapeutic Equipment............. 890.5100............... Immersion hydrobath...... 2
890.5110............... Paraffin bath............ 2
890.5500............... Infrared lamp............ 2
890.5720............... Water circulating hot or 2
cold pack.
890.5740............... Powered heating pad...... 2Radiology Panel
MRI............................... 892.1000............... Magnetic resonance 2
diagnostic device.
Ultrasound Diagnostic............. 884.2660............... Fetal ultrasonic monitor 2
and accessories.
892.1540............... Nonfetal ultrasonic
monitor.
892.1560............... Ultrasonic pulsed echo 2
imaging system.
892.1570............... Diagnostic ultrasonic 2
transducer.
892.1550............... Ultrasonic pulsed doppler
imaging system.
Angiographic...................... 892.1600............... Angiographic x-ray system 2
Diagnostic X-Ray.................. 892.1610............... Diagnostic x-ray beam- 2
limiting device.
892.1620............... Cine or spot 2
fluorographic x-ray
camera.
892.1630............... Electrostatic x-ray 2
imaging system.
892.1650............... Image-intensified 2
fluoroscopic x-ray
system.
892.1670............... Spot film device......... 2
892.1680............... Stationary x-ray system.. 2
892.1710............... Mammographic x-ray system 2
892.1720............... Mobile x-ray system...... 2
892.1740............... Tomographic x-ray system. 1
892.1820............... Pneumoencephalographic 2
chair.
892.1850............... Radiographic film 1
cassette.
892.1860............... Radiographic film/ 1
cassette changer.
892.1870............... Radiographic film/ 2
cassette changer
programmer.
892.1900............... Automatic radiographic 2
film processor.
892.1980............... Radiologic table......... 1
CT Scanner........................ 892.1750............... Computed tomography x-ray 2
system.
Radiation Therapy................. 892.5050............... Medical charged-particle 2
radiation therapy system.
892.5300............... Medical neutron radiation 2
therapy system.
892.5700............... Remote controlled 2
radionuclide applicator
system.
892.5710............... Radiation therapy beam- 2
shaping block.
892.5730............... Radionuclide 2
brachytherapy source.
892.5750............... Radionuclide radiation 2
therapy system.
892.5770............... Powered radiation therapy 2
patient support assembly.
892.5840............... Radiation therapy 2
simulation system.
892.5930............... Therapeutic x-ray tube 1
housing assembly.
Nuclear Medicine.................. 892.1170............... Bone densitometer........ 2
892.1200............... Emission computed 2
tomography system.
892.1310............... Nuclear tomography system 1
892.1390............... Radionuclide rebreathing 2
system.General/Plastic Surgery Panel
Surgical Lamps.................... 878.4630............... Ultraviolet lamp for 2
dermatologic disorders.
890.5500............... Infrared lamp............ 2
878.4580............... Surgical lamp............ 2
Electrosurgical Cutting Equipment. 878.4810............... Laser surgical instrument 2
for use in general and
plastic surgery and in
dermatology.
878.4400............... Electrosurgical cutting 2
and coagulation device
and accessories.
Miscellaneous..................... 878.4780............... Powered suction pump..... 2----------------------------------------------------------------------------------------------------------------\1\Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on
FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html. [63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]
Sec. Appendixes C-F to Subpart B of Part 26 [Reserved]