[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.50]
[Page 258-272]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 26 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE
Subpart B Specific Sector Provisions for Medical Devices
Sec. 26.50 Alert system and exchange of postmarket vigilance reports.
(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.
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 5
b. 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).
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
[[Page 259]]
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 United
States, 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,
Tracheobronchial
Cardiovascular 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 Dental
Ear, 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
[[Page 260]]
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-Stammering
Gastroenterology--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 Use
General 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, Protective
Neurology 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, Skull
Obstetrics 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--Caliper
[[Page 261]]
Physical 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,
Disposable
Radiology 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, Manual
General 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
[[Page 262]]
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 Spectroscopic
Diagnostic
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,
Diagnostic
Diagnostic 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,
Computed
ECG-Related
Devices:
CV 870.2340 Electrocardiograph
................ DPS--Electrocardiograph
................ MLC--Monitor, ST Segment
CV 870.2350 Electrocardiograph Lead Switching
Adaptor
................ DRW--Adaptor, Lead Switching,
Electrocardiograph
[[Page 263]]
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--Electroencephalograph
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, PCA
Ophthalmic
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, Steam
Clinical
Thermometers:
HO 880.2910 Clinical Electronic Thermometer
(except tympanic or pacifier)
................ FLL--Thermometer, Electronic,
Clinical
AN 868.5630 Nebulizer
................ CAF--Nebulizer (Direct Patient
Interface)
[[Page 264]]
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, Piston
Selected 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, Base
Latex 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 868.5160 Gas machine for 2
Devices anesthesia or
analgesia
868.5270 Breathing system 2
heater
868.5440 Portable oxygen 2
generator
868.5450 Respiratory gas 2
humidifier
868.5630 Nebulizer 2
868.5710 Electrically 2
powered oxygen
tent
868.5880 Anesthetic 2
vaporizer
Gas Analyser 868.1040 Powered 2
Algesimeter
868.1075 Argon gas 2
analyzer
868.1400 Carbon dioxide 2
gas analyzer
868.1430 Carbon monoxide 2
gas analyzer
868.1500 Enflurane gas 2
analyzer
868.1620 Halothane gas 2
analyzer
868.1640 Helium gas 2
analyzer
868.1670 Neon gas 2
analyzer
868.1690 Nitrogen gas 2
analyzer
868.1700 Nitrous oxide 2
gas analyzer
868.1720 Oxygen gas 2
analyzer
868.1730 Oxygen uptake 2
computer
Peripheral 868.2775 Electrical 2
Nerve peripheral
Stimulators nerve
stimulator
Respiratory 868.1750 Pressure 2
Monitoring plethysmograph
868.1760 Volume 2
plethysmograph
868.1780 Inspiratory 2
airway pressure
meter
[[Page 265]]
868.1800 Rhinoanemometer 2
868.1840 Diagnostic 2
spirometer
868.1850 Monitoring 2
spirometer
868.1860 Peak-flow meter 2
for spirometry
868.1880 Pulmonary- 2
function data
calculator
868.1890 Predictive 2
pulmonary-
function value
calculator
868.1900 Diagnostic 2
pulmonary-
function
interpretation
calculator
868.2025 Ultrasonic air 2
embolism
monitor
868.2375 Breathing 2
frequency
monitor (except
apnea
detectors)
868.2480 Cutaneous carbon 2
dioxide (PcCO2)
monitor
868.2500 Cutaneous oxygen 2
monitor (for an
infant not
under gas
anesthesia)
868.2550 Pneumotachomomet 2
er
868.2600 Airway pressure 2
monitor
868.5665 Powered 2
percussor
868.5690 Incentive 2
spirometer
Ventilator 868.5905 Noncontinuous 2
ventilator
(IPPB)
868.5925 Powered 2
emergency
ventilator
868.5935 External 2
negative
pressure
ventilator
868.5895 Continuous 2
ventilator
868.5955 Intermittent 2
mandatory
ventilation
attachment
868.6250 Portable air 2
compressor
Cardiovascular
Panel
Cardiovascula 870.1425 Programmable 2
r Diagnostic diagnostic
computer
870.1450 Densitometer 2
870.2310 Apex cardiograph 2
(vibrocardiogra
ph)
870.2320 Ballistocardiogr 2
aph
870.2340 Electrocardiogra 2
ph
870.2350 Electrocardiogra 1
ph lead
switching
adaptor
870.2360 Electrocardiogra 2
ph electrode
870.2370 Electrocardiogra 2
ph surface
electrode
tester
870.2400 Vectorcardiograp 1
h
870.2450 Medical cathode- 1
ray tube
display
870.2675 Oscillometer 2
870.2840 Apex 2
cardiographic
transducer
870.2860 Heart sound 2
transducer
Cardiovascula ................. Valve, pressure
r Monitoring relief,
cardiopulmonary
bypass
870.1100 Blood pressure 2
alarm
870.1110 Blood pressure 2
computer
870.1120 Blood pressure 2
cuff
870.1130 Noninvasive 2
blood pressure
measurement
system
870.1140 Venous blood 2
pressure
manometer
870.1220 Electrode 2
recording
catheter or
electrode
recording probe
870.1270 Intracavitary 2
phonocatheter
system
870.1875 Stethoscope 2
(electronic)
870.2050 Biopotential 2
amplifier and
signal
conditioner
870.2060 Transducer 2
signal
amplifier and
conditioner
[[Page 266]]
870.2100 Cardiovascular 2
blood flow-
meter
870.2120 Extravascular 2
blood flow
probe
870.2300 Cardiac monitor 2
(including
cardiotachomete
r and rate
alarm)
870.2700 Oximeter 2
870.2710 Ear oximeter 2
870.2750 Impedance 2
phlebograph
870.2770 Impedance 2
plethysmograph
870.2780 Hydraulic, 2
pneumatic, or
photoelectric
plethysmographs
870.2850 Extravascular 2
blood pressure
transducer
870.2870 Catheter tip 2
pressure
transducer
870.2880 Ultrasonic 2
transducer
870.2890 Vessel occlusion 2
transducer
870.2900 Patient 2
transducer and
electrode cable
(including
connector)
870.2910 Radiofrequency 2
physiological
signal
transmitter and
receiver
870.2920 Telephone 2
electrocardiogr
aph transmitter
and receiver
870.4205 Cardiopulmonary 2
bypass bubble
detector
870.4220 Cardiopulmonary 2
bypass heart-
lung machine
console
870.4240 Cardiovascular 2
bypass heat
exchanger
870.4250 Cardiopulmonary 2
bypass
temperature
controller
870.4300 Cardiopulmonary 2
bypass gas
control unit
870.4310 Cardiopulmonary 2
bypass coronary
pressure gauge
870.4330 Cardiopulmonary 2
bypass on-line
blood gas
monitor
870.4340 Cardiopulmonary 2
bypass level
sensing monitor
and/or control
870.4370 Roller-type 2
cardiopulmonary
bypass blood
pump
870.4380 Cardiopulmonary 2
bypass pump
speed control
870.4410 Cardiopulmonary 2
bypass in-line
blood gas
sensor
Cardiovascula 870.5050 Patient care 2
r suction
Therapeutic apparatus
870.5900 Thermal 2
regulation
system
Defibrillator 870.5300 DC-defibrillator 2
(including
paddles)
870.5325 Defibrillator 2
tester
Echocardiogra 870.2330 Echocardiograph 2
ph
Pacemaker & 870.1750 External 2
Accessories programmable
pacemaker pulse
generator
870.3630 Pacemaker 2
generator
function
analyzer
870.3640 Indirect 2
pacemaker
generator
function
analyzer
870.3720 Pacemaker 2
electrode
function tester
Miscellaneous 870.1800 Withdrawal- 2
infusion pump
870.2800 Medical magnetic 2
tape recorder
None Batteries,
rechargeable,
class II
devices
[[Page 267]]
Dental Panel
Dental 872.1720 Pulp tester 2
Equipment
872.1740 Caries detection 2
device
872.4120 Bone cutting 2
instrument and
accessories
872.4465 Gas-powered jet 2
injector
872.4475 Spring-powered 2
jet injector
872.4600 Intraoral 2
ligature and
wire lock
872.4840 Rotary scaler 2
872.4850 Ultrasonic 2
scaler
872.4920 Dental 2
electrosurgical
unit and
accessories
872.6070 Ultraviolet 2
activator for
polymerization
872.6350 Ultraviolet 2
detector
Dental 872.3050 Amalgam alloy 2
Material
872.3060 Gold-based 2
alloys and
precious metal
alloys for
clinical use
872.3200 Resin tooth 2
bonding agent
872.3250 Calcium 2
hydroxide
cavity liner
872.3260 Cavity varnish 2
872.3275 Dental cement 2
(other than
zinc oxide-
eugenol)
872.3300 Hydrophilic 2
resin coating
for dentures
872.3310 Coating material 2
for resin
fillings
872.3590 Preformed 2
plastic denture
tooth
872.3660 Impression 2
material
872.3690 Tooth shade 2
resin material
872.3710 Base metal alloy 2
872.3750 Bracket adhesive 2
resin and tooth
conditioner
872.3760 Denture 2
relining,
repairing, or
rebasing resin
872.3765 Pit and fissure 2
sealant and
conditioner
872.3770 Temporary crown 2
and bridge
resin
872.3820 Root canal 2
filling resin
(other than
chloroform use)
872.3920 Porcelain tooth 2
Dental X-ray 872.1800 Extraoral source 2
x-ray system
872.1810 Intraoral source 2
x-ray system
Dental 872.4880 Intraosseous 2
Implants fixation screw
or wire
872.3890 Endodontic 2
stabilizing
splint
Orthodontic 872.5470 Orthodontic 2
plastic bracket
Ear/Nose/Throat
Panel
Diagnostic 874.1050 Audiometer 2
Equipment
874.1090 Auditory 2
impedance
tester
874.1120 Electronic noise 2
generator for
audiometric
testing
874.1325 Electroglottogra 2
ph
874.1820 Surgical nerve 2
stimulator/
locator
Hearing Aids 874.3300 Hearing aid (for 2
bone-
conduction)
874.3310 Hearing aid 2
calibrator and
analysis system
874.3320 Group hearing 2
aid or group
auditory
trainer
874.3330 Master hearing 2
aid
Surgical 874.4250 Ear, nose, and 1
Equipment throat electric
or pneumatic
surgical drill
874.4490 Argon laser for 2
otology,
rhinology, and
laryngology
[[Page 268]]
874.4500 Ear, nose, and 2
throat
microsurgical
carbon dioxide
laser
Gastroenterology/
Urology Panel
Endoscope 876.1500 Endoscope and 2
(including accessories
angioscopes,
laparscopes,
ophthalmic
endoscopes)
876.4300 Endoscopic 2
electrosurgical
unit and
accessories
Gastroenterol 876.1725 Gastrointestinal 1
ogy motility
monitoring
system
Hemodialysis 876.5600 Sorbent 2
regenerated
dialysate
delivery system
for
hemodialysis
876.5630 Peritoneal 2
dialysis system
and accessories
876.5665 Water 2
purification
system for
hemodialysis
876.5820 Hemodialysis 2
system and
accessories
876.5830 Hemodialyzer 2
with disposable
insert (kiil-
type)
Lithotriptor 876.4500 Mechanical 2
lithotriptor
Urology 876.1620 Urodynamics 2
Equipment measurement
system
876.5320 Nonimplanted 2
electrical
continence
device
876.5880 Isolated kidney 2
perfusion and
transport
system and
accessories
General Hospital
Panel
Infusion 880.2420 Electronic 2
Pumps and monitor for
Systems gravity flow
infusion
systems
880.2460 Electrically 2
powered spinal
fluid pressure
monitor
880.5430 Nonelectrically 2
powered fluid
injector
880.5725 Infusion pump 2
Neonatal 880.5400 Neonatal 2
Incubators incubator
880.5410 Neonatal 2
transport
incubator
880.5700 Neonatal 2
phototherapy
unit
Piston 880.5570 Hypodermic 1
Syringes single lumen
needle
880.5860 Piston syringe 1
(except
antistick)
880.6920 Syringe needle 2
introducer
Miscellaneous 880.2910 Clinical 2
electronic
thermometer
880.2920 Clinical mercury 2
thermometer
880.5100 AC-powered 1
adjustable
hospital bed
880.5500 AC-powered 2
patient lift
880.6880 Steam sterilizer 2
(greater than 2
cubic feet)
Neurology Panel
882.1020 Rigidity 2
analyzer
882.1610 Alpha monitor 2
Neuro- 882.1320 Cutaneous 2
Diagnostic electrode
882.1340 Nasopharyngeal 2
electrode
882.1350 Needle electrode 2
882.1400 Electroencephalo 2
graph
882.1460 Nystagmograph 2
882.1480 Neurological 2
endoscope
882.1540 Galvanic skin 2
response
measurement
device
882.1550 Nerve conduction 2
velocity
measurement
device
882.1560 Skin potential 2
measurement
device
[[Page 269]]
882.1570 Powered direct- 2
contact
temperature
measurement
device
882.1620 Intracranial 2
pressure
monitoring
device
882.1835 Physiological 2
signal
amplifier
882.1845 Physiological 2
signal
conditioner
882.1855 Electroencephalo 2
gram (EEG)
telemetry
system
882.5050 Biofeedback 2
device
Echoencephalo 882.1240 Echoencephalogra 2
graphy ph
RPG 882.4400 Radiofrequency 2
lesion
generator
Neuro Surgery none Electrode, 2
spinal epidural
882.4305 Powered compound 2
cranial drills,
burrs,
trephines, and
their
accessories
882.4310 Powered simple 2
cranial drills
burrs,
trephines, and
their
accessories
882.4360 Electric cranial 2
drill motor
882.4370 Pneumatic 2
cranial drill
motor
882.4560 Stereotaxic 2
instrument
882.4725 Radiofrequency 2
lesion probe
882.4845 Powered rongeur 2
882.5500 Lesion 2
temperature
monitor
Stimulators 882.1870 Evoked response 2
electrical
stimulator
882.1880 Evoked response 2
mechanical
stimulator
882.1890 Evoked response 2
photic
stimulator
882.1900 Evoked response 2
auditory
stimulator
882.1950 Tremor 2
transducer
882.5890 Transcutaneous 2
electrical
nerve
stimulator for
pain relief
Obstetrics/
Gynecology Panel
Fetal 884.1660 Transcervical 2
Monitoring endoscope
(amnioscope)
and accessories
884.1690 Hysteroscope and 2
accessories
(for
performance
standards)
884.2225 Obstetric- 2
gynecologic
ultrasonic
imager
884.2600 Fetal cardiac 2
monitor
884.2640 Fetal 2
phonocardiograp
hic monitor and
accessories
884.2660 Fetal ultrasonic 2
monitor and
accessories
884.2675 Fetal scalp 1
circular
(spiral)
electrode and
applicator
884.2700 Intrauterine 2
pressure
monitor and
accessories
884.2720 External uterine 2
contraction
monitor and
accessories
884.2740 Perinatal 2
monitoring
system and
accessories
884.2960 Obstetric 2
ultrasonic
transducer and
accessories
Gynecological 884.1720 Gynecologic 2
Surgery laparoscope and
Equipment accessories
884.4160 Unipolar 2
endoscopic
coagulator-
cutter and
accessories
884.4550 Gynecologic 2
surgical laser
884.4120 Gynecologic 2
electrocautery
and accessories
884.5300 Condom 2
[[Page 270]]
Ophthalmic 886.3320 Eye sphere 2
Implants implant
Contact Lens 886.1385 Polymethylmethac 2
rylate (PMMA)
diagnostic
contact lens
886.5916 Rigid gas 2
permeable
contact lens
(daily wear
only)
Diagnostic 886.1120 Opthalmic camera 1
Equipment
886.1220 Corneal 1
electrode
886.1250 Euthyscope (AC- 1
powered)
886.1360 Visual field 1
laser
instrument
886.1510 Eye movement 1
monitor
886.1570 Ophthalmoscope 1
886.1630 AC-powered 1
photostimulator
886.1640 Ophthalmic 1
preamplifier
886.1670 Ophthalmic 2
isotope uptake
probe
886.1780 Retinoscope (AC- 1
powered device)
886.1850 AC-powered slit 1
lamp
biomicroscope
886.1930 Tonometer and 2
accessories
886.1945 Transilluminator 1
(AC-powered
device)
886.3130 Ophthalmic 2
conformer
(Diagnostic/ 886.4670 Phacofragmentati 2
Surgery on system
Equipment)
Ophthalmic 886.3340 Extraocular 2
Implants orbital implant
886.3800 Scleral shell 2
Surgical 880.5725 Infusion pump 2
Equipment (performance
standards)
886.3100 Ophthalmic 2
tantalum clip
886.3300 Absorbable 2
implant
(scleral
buckling
method)
886.4100 Radiofrequency 2
electrosurgical
cautery
apparatus
886.4115 Thermal cautery 2
unit
886.4150 Vitreous 2
aspiration and
cutting
instrument
886.4170 Cryophthalmic 2
unit
886.4250 Ophthalmic 1
electrolysis
unit (AC-
powered device)
886.4335 Operating 1
headlamp (AC-
powered device)
886.4390 Ophthalmic laser 2
886.4392 Nd:YAG laser for 2
posterior
capsulotomy
886.4400 Electronic metal 1
locator
886.4440 AC-powered 1
magnet
886.4610 Ocular pressure 2
applicator
886.4690 Ophthalmic 2
photocoagulator
886.4790 Ophthalmic 2
sponge
886.5100 Ophthalmic beta 2
radiation
source
none Ophthalmoscopes, 1
replacement
batteries, hand-
held
Orthopedic Panel
Implants 888.3010 Bone fixation 2
cerclage
888.3020 Intramedullary 2
fixation rod
888.3030 Single/multiple 2
component
metallic bone
fixation
appliances and
accessories
888.3040 Smooth or 2
threaded
metallic bone
fixation
fastener
888.3050 Spinal 2
interlaminal
fixation
orthosis
888.3060 Spinal 2
intervertebral
body fixation
orthosis
Surgical 888.1240 AC-powered 2
Equipment dynamometer
888.4580 Sonic surgical 2
instrument and
accessories/
attachments
[[Page 271]]
none Accessories, 2
fixation,
spinal
interlaminal
none Accessories, 2
fixation,
spinal
intervertebral
body
none Monitor, 1
pressure,
intracompartmen
tal
none Orthosis, 2
fixation,
spinal
intervertebral
fusion
none Orthosis, spinal
pedicle
fixation
none System, cement 1
removal
extraction
Physical Medicine
Panel
Diagnostic 890.1225 Chronaximeter 2
Equipment or
(Therapy)
Therapeutic
Equipment
890.1375 Diagnostic 2
electromyograph
890.1385 Diagnostic 2
electromyograph
needle
electrode
890.1450 Powered reflex 2
hammer
890.1850 Diagnostic 2
muscle
stimulator
or (Therapy) 890.5850 Powered muscle 2
stimulator
Therapeutic 890.5100 Immersion 2
Equipment hydrobath
890.5110 Paraffin bath 2
890.5500 Infrared lamp 2
890.5720 Water 2
circulating hot
or cold pack
890.5740 Powered heating 2
pad
Radiology Panel
MRI 892.1000 Magnetic 2
resonance
diagnostic
device
Ultrasound 884.2660 Fetal ultrasonic 2
Diagnostic monitor and
accessories
892.1540 Nonfetal
ultrasonic
monitor
892.1560 Ultrasonic 2
pulsed echo
imaging system
892.1570 Diagnostic 2
ultrasonic
transducer
892.1550 Ultrasonic
pulsed doppler
imaging system
Angiographic 892.1600 Angiographic x- 2
ray system
Diagnostic X- 892.1610 Diagnostic x-ray 2
Ray beam-limiting
device
892.1620 Cine or spot 2
fluorographic x-
ray camera
892.1630 Electrostatic x- 2
ray imaging
system
892.1650 Image- 2
intensified
fluoroscopic x-
ray system
892.1670 Spot film device 2
892.1680 Stationary x-ray 2
system
892.1710 Mammographic x- 2
ray system
892.1720 Mobile x-ray 2
system
892.1740 Tomographic x- 1
ray system
892.1820 Pneumoencephalog 2
raphic chair
892.1850 Radiographic 1
film cassette
892.1860 Radiographic 1
film/cassette
changer
892.1870 Radiographic 2
film/cassette
changer
programmer
892.1900 Automatic 2
radiographic
film processor
892.1980 Radiologic table 1
CT Scanner 892.1750 Computed 2
tomography x-
ray system
Radiation 892.5050 Medical charged- 2
Therapy particle
radiation
therapy system
892.5300 Medical neutron 2
radiation
therapy system
[[Page 272]]
892.5700 Remote 2
controlled
radionuclide
applicator
system
892.5710 Radiation 2
therapy beam-
shaping block
892.5730 Radionuclide 2
brachytherapy
source
892.5750 Radionuclide 2
radiation
therapy system
892.5770 Powered 2
radiation
therapy patient
support
assembly
892.5840 Radiation 2
therapy
simulation
system
892.5930 Therapeutic x- 1
ray tube
housing
assembly
Nuclear 892.1170 Bone 2
Medicine densitometer
892.1200 Emission 2
computed
tomography
system
892.1310 Nuclear 1
tomography
system
892.1390 Radionuclide 2
rebreathing
system
General/Plastic
Surgery Panel
Surgical 878.4630 Ultraviolet lamp 2
Lamps for
dermatologic
disorders
890.5500 Infrared lamp 2
878.4580 Surgical lamp 2
Electrosurgic 878.4810 Laser surgical 2
al Cutting instrument for
Equipment use in general
and plastic
surgery and in
dermatology
878.4400 Electrosurgical 2
cutting and
coagulation
device and
accessories
Miscellaneous 878.4780 Powered suction 2
pump
------------------------------------------------------------------------
\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]
Appendixes C-F to Subpart B of Part 26 [Reserved]
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© 2007 Betterchem Corp.
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