Explanatory Memorandum to COM(2000)350 - EC position for a decision of the Joint Committee on amending certain Sectoral Annexes to the Agreement on Mutual Recognition between the EC and the USA - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2000)350 - EC position for a decision of the Joint Committee on amending certain Sectoral Annexes to the Agreement on Mutual ... |
|---|---|
| source | COM(2000)350  |
| date | 30-06-2000 |
1. The Agreement on Mutual Recognition between the European Community (EC) and the United States of America (US) was approved by the Council by its Decision of 22 June 1998 i and entered into force on 1 December 1998.
2. Article 21 i of the Agreement foresees that the Sectoral Annexes can be amended by the Parties through the Joint Committee, set up under Article 14 of the Agreement. According to Article 3 i of Council Decision 1999/78/EC, the position of the Community with regard to decisions to be taken by the Joint Committee within the framework of Article 21 of the Agreement, shall be determined by the Council, acting by qualified majority on a proposal from the Commission.
3. Both the Community and the US have identified the need for amending certain Sectoral Annexes to the Agreement to reflect their current legislative and regulatory situation.
Contents
- II Amendments to the Sectoral Annex for Telecommunications Equipment (TTE)
- III. Amendments to the Sectoral Annex for Electromagnetic Compatibility (EMC)
- IV. Amendments to the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)
- Because equivalence is the cornerstone of this Annex, the Authorities of the Parties will maintain their respective requirements and will carry out the inspections against their own requirements."
- Article 1
- Article 2
- Article 3
- For the Council
- 1. Amendments to the Sectoral Annex for Telecommunications Equipment
- 2. Amendments to the Sectoral Annex for Electromagnetic Compatibility (EMC)
- 3. Amendments to the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)
- Because equivalence is the cornerstone of this Annex, the Authorities of the Parties will maintain their respective requirements and will carry out the inspections against their own requirements."
- 4. Amendments to the Sectoral Annex for Medical Devices
- TABLE 1
- 872.4200 // DENTAL HANDPIECES AND ACCESSORIES
- 872.6250 // DENTAL CHAIR AND ACCESSORIES
- 872.6640 // DENTAL OPERATIVE UNIT AND ACCESSORIES
- 872.6710 // BOILING WATER STERILIZER
- 1.1. GASTROENTEROLOGY-UROLOGY PANEL
- 876.5160 // UROLOGICAL CLAMPS FOR MALES
- 878.4460 // SURGEON'S GLOVES
- 880.5090 // LIQUID BANDAGE
- 880.5680 // PEDIATRIC POSITION HOLDER
- 880.6250 // PATIENT EXAMINATION GLOVE
- 880.6375 // PATIENT LUBRICANT
- 880.6760 // PROTECTIVE RESTRAINT
- 882.1030 // ATAXIAGRAPH
- 882.1420 // ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER
- 882.4060 // VENTRICULAR CANNULA
- 882.4545 // SHUNT SYSTEM IMPLANTATION INSTRUMENT
- 884.2980 // THERMOGRAPHIC SYSTEM
- 884.2982 // LIQUID CRYSTAL TELETHERMOGRAPHIC SYSTEM
- 886.4070 // POWERED CORNEAL BURR
- 886.4300 // INTRAOCULAR LENS GUIDE
- 886.4370 // KERATOME
- 888.1500 // GONIOMETER
- 890.3850 // MECHANICAL WHEELCHAIR
- 890.5710 // HOT OR COLD DISPOSABLE PACK
- 892.1100 // SCINTILLATION (GAMMA) CAMERA
- 892.1110 // POSITRON CAMERA
- TABLE 2
- 868.5630 // NEBULIZER
- 870.1120 // BLOOD PRESSURE CUFF
- 870.1130 // NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-oscillometric)
- 870.2300 // CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM)
- 870.2330 // ECHOCARDIOGRAPH
- 870.2340 // ELECTROCARDIOGRAPH
- 870.2350 // ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
- 870.2360 // ELECTROCARDIOGRAPH ELECTRODE
- 870.2370 // ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER
- 870.2880 // ULTRASONIC TRANSDUCER
- 872.3060 // GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE
- 872.3200 // RESIN TOOTH BONDING AGENT
- 872.3275 // DENTAL CEMENT
- 872.3660 // IMPRESSION MATERIAL
- 872.3690 // TOOTH SHADE RESIN MATERIAL
- 872.3710 // BASE METAL ALLOY
- 876.1075 // GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
- 876.1500 // ENDOSCOPE AND ACCESSORIES
- // FDW - ESOPHAGOSCOPE, RIGID, GASTRO-UROLOGY
- // FFS - ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE
- // FBP - TELESCOPE, RIGID, ENDOSCOPIC
- 876.4500 // MECHANICAL LITHOTRIPTER
- 876.5010 // BILIARY CATHETER AND ACCESSORIES (biliary stone dislodger only)
- 876.5320 // NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
- 876.5665 // WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- 880.2910 // CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier)
- 880.5400 // NEONATAL INCUBATOR
- 880.5410 // NEONATAL TRANSPORT INCUBATOR
- 880.5570 // HYPODERMIC SINGLE LUMEN NEEDLE
- 880.5725 // INFUSION PUMP (external only)
- 880.5860 // PISTON SYRINGE
- 880.6880 // STEAM STERILIZER (greater than 2 cubic feet)
- 882.1240 // ECHOENCEPHALOGRAPH
- 882.1320 // CUTANEOUS ELECTRODE
- 882.1400 // ELECTROENCEPHALOGRAPH
- 882.1480 // NEUROLOGICAL ENDOSCOPE
- 882.5890 // TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF
- 884.1690 // HYSTEROSCOPE AND ACCESSORIES
- 884.1720 // GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
- 884.2225 // OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER
- 884.2660 // FETAL ULTRASONIC MONITOR AND ACCESSORIES
- 884.2960 // OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES
- 884.5300 // CONDOM
- 886.1570 // OPHTHALMOSCOPE
- 886.1780 // RETINOSCOPE
- 886.1850 // AC-POWERED SLIT-LAMP BIOMICROSCOPE
- 886.4150 // VITREOUS ASPIRATION AND CUTTING INSTRUMENT
- 886.4670 // PHACOFRAGMENTATION SYSTEM
- 888.1100 // ARTHROSCOPE
- 884.2660 // FETAL ULTRASONIC MONITOR AND ACCESSORIES
- 892.1000 // MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- 892.1200 // EMISSION COMPUTED TOMOGRAPHY SYSTEM
- 892.1310 // NUCLEAR TOMOGRAPHY SYSTEM
- 892.1360 // RADIONUCLIDE DOSE CALIBRATOR
- 892.1540 // NONFETAL ULTRASONIC MONITOR
- 892.1550 // ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
- 892.1560 // ULTRASONIC PULSED ECHO IMAGING SYSTEM
- 892.1570 // DIAGNOSTIC ULTRASONIC TRANSDUCER
- 892.1600 // ANGIOGRAPHIC X-RAY SYSTEM
- 892.1610 // DIAGNOSTIC X-RAY BEAM LIMITING DEVICE
- 892.1620 // CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA
- 892.1630 // ELECTROSTATIC X-RAY IMAGING SYSTEM
- 892.1650 // IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM (except solid state)
- 892.1670 // SPOT FILM DEVICE
- 892.1680 // STATIONARY X-RAY SYSTEM
- 892.1720 // MOBILE X-RAY SYSTEM
- 892.1740 // TOMOGRAPHIC X-RAY SYSTEM
- 892.1750 // COMPUTED TOMOGRAPHY X-RAY SYSTEM
- 892.1820 // PNEUMOENCEPHALOGRAPHIC CHAIR
- 892.1850 // RADIOGRAPHIC FILM CASSETTE
- 892.1860 // RADIOGRAPHIC FILM/CASSETTE CHANGER
- 892.1870 // RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER
- 892.1900 // AUTOMATIC RADIOGRAPHIC FILM PROCESSOR
- // PRODUCT CODE - DEVICE NAME
- 876.1500 // ENDOSCOPE AND ACCESSORIES
- 878.4400 // ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
- // JOS - ELECTRODE, ELECTROSURGICAL
- 878.4580 // SURGICAL LAMP
- 878.4780 // POWERED SUCTION PUMP
4. Directive 1999/5/EC on radio equipment and telecommunications terminal equipment i was adopted on 9 March 1999 and will repeal directive 1998/13/EC i as of 8 April 2000. The existing TTE Sectoral Annex makes a reference to directive 1998/13/EC and it must therefore be up-dated to take into account the new legal situation in the Community. More in detail, the amendments reflect the following:
- Changed scope between directive 1998/13/EC and 1999/5/EC.
- Changed conformity assessment procedures between the directives.
- Changed relation to directive 1973/23/EEC on low voltage equipment and directive 1989/336/EEC on electromagnetic compatibility.
5. The US has proposed that the Federal Aviation Administration (FAA) be removed from the list of US designating Authorities indicated in Section IV. The reason being that the FAA does not have the legal authority to carry the responsibility of a designating authority. Therefore, for the US, the National Institute for Standards and Technology (NIST) and the Federal Communications Commission (FCC) exclusively shall serve as the only US authorities under Section IV to designate the conformity assessment bodies listed in Section V. This does not appear to cause problems for the good functioning of the MRA in this sector.
6. The US has noted that Article 1 i of the Annex for GMPs states that the EC and US have agreed to reconsider the concepts of GMPs reproduced in that provision. Therefore, the US has proposed to clarify that, under the Agreement, the first paragraph of Article 1 i has to be understood as the US definition and the second as the EC definition. Further, because equivalence is the cornerstone of the GMPs Annex, the US understands that the EC and the US shall maintain their respective requirements and shall carry out the inspections in accordance with their own requirements. In order to reflect this the US has proposed the following modification of Article 1 i of the GMPs Annex (modifications compared to the existing text are underlined):
"3. Good Manufacturing Practices
In the United States, GMPs mean the requirements found in the legislation, regulations and administrative provisions for methods to be used in, and the facilities or controls to be used for, the manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safety, and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
In the EC, GMPs are the part of quality assurance which ensures that products are consistently produced and controlled to a quality standard. GMPs include, therefore, the system whereby the manufacturer receives the specifications of the product and/or process from the marketing authorisation/product authorisation or license holder or applicant and ensures the product is made in compliance with its specifications (qualified person certification).
Because equivalence is the cornerstone of this Annex, the Authorities of the Parties will maintain their respective requirements and will carry out the inspections against their own requirements."
V. Amendments to the Sectoral Annex for Medical Devices
7. The US wishes to revise Tables 1 and 2 of the Sectoral Annex for Medical Devices, which contain the lists of medical devices eligible for premarket assessment under the Agreement, in order to achieve consistency with US legislation currently in place.
8. The changes in Table 1 reflect the fact that only 25 categories of non-in vitro diagnostic class I devices need premarket notifications, as a result of the Food and Drug Administration Modernization ACT (FDAMA), which was enacted into law on 21 November 1997. The US proposes to add 6 categories to Table 1, while 44 categories should be removed (in vitro diagnostic devices are not covered by the Agreement). All 25 remaining categories are eligible for third party reviews and therefore premarket assessment under the Agreement.
9. The changes in Table 2 are also required as a result of the enactment of FDAMA. The United States considers that it is unable to accept reviews by accredited persons of premarket notifications for 4 categories of devices, because the FDAMA includes explicit language that prohibits use of third party bodies for the review of a class II medical device which is intended to be permanently implantable or life sustaining or life supporting.
10. For Table 2 the US also proposes to expand the scope of product coverage for class II medical devices eligible for third party pre-market assessment under the Agreement. The US proposes to add to Table 2 an additional 34 device categories that have become eligible for third party pre-market assessment under the FDAMA. 30 of the 34 additions are devices that the Community have previously expressed interest in including in the Agreement.
11. With these proposed changes, there will be a net decrease in the number of class I medical devices in Table 1 (from 63 to 25 categories), reflecting FDAMA regulatory simplification. The class I devices removed from Table 1 no longer require pre-market notification for marketing in the US. For Table 2, the addition of 34 categories of class II devices and the deletion of 4 ineligible categories will result in a net increase from 42 to 72 categories of class II devices. On balance, therefore, these changes would expand the scope of application of the MRA in this sector.
Proposal for a COUNCIL DECISION determining the Community position for a decision of the Joint Committee on amending certain Sectoral Annexes to the Agreement on Mutual Recognition between the European Community and the United States of America
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to the Council Decision of 22 June 1998 on the conclusion of an Agreement on Mutual Recognition between the European Community and the United States of America i and in particular Article 3 i of that Decision,
Having regard to the proposal from the Commission [5],
[5]
Whereas both the Community and the United States of America have identified the need of amending certain Sectoral Annexes of the Mutual Recognition Agreement in order to reflect their current legislative and regulatory situation,
HAS DECIDED AS FOLLOWS:
The position to be adopted by the European Community for a decision by the Joint Committee, set up under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, on amending the Sectoral Annexes on Telecommunications Equipment, Electromagnetic Compatibility, Pharmaceutical Good Manufacturing Practices (GMPs) and Medical Devices shall be based on the amendments specified in the annex to this Decision. Minor modifications to the amendments specified in the annex may be accepted without further decision by the Council.
The Council authorises the Commission to sign on behalf of the Community the decision of the Joint Committee that adopts the amendments mentioned in Article 1.
The Decision of the Joint Committee shall be published in the Official Journal once it has been adopted.
Done at Brussels,
The President
ANNEX
1. In Section I, under the EC, the whole text is replaced with the following:
"Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity"
2. In Section III, paragraph 2(c) 'Directive 98/13/EC' is deleted and replaced with 'Directive 1999/5/EC'.
3. In Section III, paragraph 2 the following subparagraphs are added:
"(d) prescription of radio tests to be performed pursuant to annexes III and IV of Directive 1999/5/EC.
(e) issuing of an opinion on a technical file pursuant to annex V of Directive 1999/5/EC."
4. In Appendix I, 'ACTE Approval Committee for Terminal Equipment', 'ADLNB Association of Designated Laboratories and Notified Bodies' and 'CTR Common Technical Regulations' are deleted.
1. In Section IV, under the 'U.S.' column, 'Federal Aviation Administration (FAA)' is deleted.
Article 1, paragraph 3 is deleted in its entirety and is replace with the following text:
"3. Good Manufacturing Practices (GMPs)
In the United States, GMPs means the requirements found in the legislation, regulations and administrative provisions for methods to be used in, and the facilities or controls to be used for, the manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safety, and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
In the EC, GMPs are the part of quality assurance which ensures that products are consistently produced and controlled to a quality standard. GMPs include, therefore, the system whereby the manufacturer receives the specifications of the products and/or process from the marketing authorisation/product authorisation or license holder or applicant and ensures the product is made in compliance with its specifications (qualified person certification).
Because equivalence is the cornerstone of this Annex, the Authorities of the Parties will maintain their respective requirements and will carry out the inspections against their own requirements."
1. Table 1 is deleted in its entirety and is replaced with the following text:
Class I products requiring premarket evaluations in the United States, included in scope of product coverage at beginning of transition period
DENTAL PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// EBW - CONTROLLER, FOOT, 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
// KLC - CHAIR WITH A UNIT
// DYN - MOUTHPIECE, SALIVA EJECTOR
// EBR - UNIT, SUCTION OPERATORY
// EHZ - EVACUATOR, ORAL CAVITY
// EIA - UNIT, OPERATIVE DENTAL
// ECG - STERILIZER, BOILING WATER
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// FHA - CLAMP, PENILE
GENERAL AND PLASTIC SURGERY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// KGO - SURGEON'S GLOVES
// KMF - BANDAGE, LIQUID
GENERAL HOSPITAL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// FRP - HOLDER, INFANT POSITION
// 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
// KMJ - LUBRICANT, PATIENT
// MMS - LUBRICANT, VAGINAL, PATIENT
// BRT - RESTRAINT, PATIENT, CONDUCTIVE
// FMQ - RESTRAINT, PROTECTIVE
NEUROLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// GWW - ATAXIAGRAPH
// GWS - ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL
// HCD - CANNULA, VENTRICULAR
// GYK - INSTRUMENT, SHUNT SYSTEM IMPLANTATION
OBSTETRICS AND GYNECOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// LHQ - SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)
// LHM - SYSTEM, TELETHERMOGRAPHIC, LIQUID CRYSTAL
// KYA - SYSTEM, TELETHERMOGRAPHIC, LIQUID CRYSTAL, NONPOWERED (ADJUNCTIVE USE)
OPHTHALMOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// HQS - BURR, CORNEAL, AC-POWERED
// HOG - BURR, CORNEAL, BATTERY-POWERED
// HRG - ENGINE, TREPHINE, ACCESSORIES, AC-POWERED
// HRF - ENGINE, TREPHINE, ACCESSORIES, BATTERY-POWERED
// HLD - ENGINE, TREPHINE, ACCESSORIES, GAS-POWERED
// KYB - LENS, GUIDE, INTRAOCULAR
// HNO - KERATOME, AC-POWERED
// HMY - KERATOME, BATTERY-POWERED
ORTHOPEDIC PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// KQX - GONIOMETER, AC-POWERED
PHYSICAL MEDICINE PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// LBE - STROLLER, ADAPTIVE
// IOR - WHEELCHAIR, MECHANICAL
// IMD - PACK, HOT OR COLD, DISPOSABLE
RADIOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// IYX - CAMERA, SCINTILLATION (GAMMA)
// IZC - CAMERA, POSITRON
2. Table 2 is deleted in its entirety and is replaced with the following text:
Class II medical devices included in the scope of product coverage at beginning of transitional period
(US to develop guidance documents identifying US requirements and EC to identify standards needed to meet EV requirements)
ANESTHESIOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// CAF - NEBULIZER (DIRECT PATIENT INTERFACE)
CARDIOVASCULAR PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
DXQ - CUFF, BLOOD-PRESSURE
// DXN - SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
DRT - MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
// DXK - ECHOCARDIOGRAPH
DPS - ELECTROCARDIOGRAPH
MLC - MONITOR, ST SEGMENT (without alarm)
// DRW - ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH
// DRX - ELECTRODE, ELECTROCARDIOGRAPH
// KRC - TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC
// JOP - TRANSDUCER, ULTRASONIC
DENTAL PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// EJT - ALLOY, GOLD BASED, FOR CLINICAL USE
// EJS - ALLOY, PRECIOUS METAL, FOR CLINICAL USE
// KLE - AGENT, TOOTH BONDING, RESIN
EMA - CEMENT, DENTAL
EMB - ZINC OXIDE EUGENOL
ELW - MATERIAL, IMPRESSION
// EBF - MATERIAL, TOOTH SHADE, RESIN
// EJH - METAL, BASE
GASTROENTEROLOGY-UROLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// KNW - INSTRUMENT, BIOPSY
// FCF - INSTRUMENT, BIOPSY, MECHANICAL, GASTROINTESTINAL
// FCK - INSTRUMENT, BIOPSY, SUCTION
// FCI - PUNCH, BIOPSY
// FCG - SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY
// FEB - ACCESSORIES, CLEANING FOR ENDOSCOPE
// FER - ANOSCOPE, NON-POWERED
// FDP - APPARATUS, PNEUMOPERITONEUM, AUTOMATIC
// FDX - BRUSH, CYTOLOGY, FOR ENDOSCOPE
// FGS - CARRIER, SPONGE, ENDOSCOPIC
// FBN - CHOLEDOCHOSCOPE, FLEXIBLE OR RIGID
// FDF - COLONOSCOPE, GASTRO-UROLOGY
// FTJ - COLONOSCOPE, GENERAL AND PLASTIC SURGERY
// FFZ - CORD, ELECTRIC, FOR ENDOSCOPE
// FAJ - CYTOSCOPE, DIAGNOSTIC
// FBO - CYSTOURETHROSCOPE
// FDT - DUODEDOSCOPE, ESOPHAGO GASTRO
// KOG - ENDOSCOPE AND/OR ACCESSORIES
// GCP - ENDOSCOPE, AC-POWERED AND ACCESSORIES
// GCS - ENDOSCOPE, BATTERY-POWERED AND ACCESSORIES
// GCR - ENDOSCOPE, DIRECT VISION
// GDB - ENDOSCOPE, FIBER OPTIC
// GCQ - ENDOSCOPE, FLEXIBLE
// GCO - ENDOSCOPE, MIRROR
// GCN - ENDOSCOPE, PRISM
// GCM - ENDOSCOPE, RIGID
// FDA - ENTEROSCOPE
// GCL - ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY
// FDS - GASTROSCOPE, GASTRO-UROLOGY
// GCK - GASTROSCOPE, GENERAL & PLASTIC SURGERY
// FCX - INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
// FHX - JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT
// FTI - LAMP, ENDOSCOPE, INCANDESCENT
// GCI - LARYNGOSCOPE
// GCT - LIGHT SOURCE, ENDOSCOPIC, XENON ARC
// FCW - LIGHT SOURCE, FIBEROPTIC, ROUTINE
// FCQ - LIGHT SOURCE, INCONDESCENT, DIAGNOSTIC
// FCR - LIGHT SOURCE, PHOTOGRAPHIC, FIBEROPTIC
// GCH - MEDIASTINOSCOPE
// FBK - NEEDLE, ENDOSCOPIC
// FHP - NEEDLE, PNEUMOPERITONEUM, SIMPLE
// FHO - NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
// FEC - OBTURATOR, FOR ENDOSCOPE
// FTK - PANCREATOSCOPE, BILIARY
// FAK - PANENDOSCOPE (GASTRODUODENOSCOPE)
// FAL - PANENDOSCOPE (URETHROSCOPE)
// GCG - PERITONEOSCOPE
// GCF - PROCTOSCOPE
// FEQ - PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
// FJL - RESECTOSCOPE
// FDC - RESECTOSCOPE, WORKING ELEMENT
// FCC - RETRIEVER, ENDOMAGNETIC
// FBI - RONGEUR, CYTOSCOPIC
// KDO - RONGEUR, CYSTOSCOPIC, HOT
// KGD - SCISSORS FOR CYTOSCOPE
// FDE - SET, LAPAROSCOPY
// FGA - SET, NEPHROSCOPE
// FED - SHEATH, FOR ENDOSCOPE
// FAM - SIGMOIDOSCOPE, FLEXIBLE
// FAN - SIGMOIDOSCOPE, RIGID, ELECTRICAL
// KDM - SIGMOIDOSCOPE, RIGID, NON-ELECTRICAL
// FDR - SPHYNCTEROSCOPE
// FET - TAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC
// GCW - TRANSFORMER, ENDOSCOPE
// FGB - URETEROSCOPE
// FGC - URETHROSCOPE
// LQC - LITHOTRIPTER, BILIARY MECHANICAL
// FGK - TRIPSOR, STONE, BLADDER
// LQR - DISLODGER, STONE, BILIARY
// KPI - STIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE)
// FIP - SUBSYSTEM, WATER PURIFICATION
GENERAL HOSPITAL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// FLL - THERMOMETER, ELECTRONIC, CLINICAL
FMZ - INCUBATOR, NEONATAL
FPL - INCUBATOR, NEONATAL TRANSPORT
// MMK - CONTAINER, SHARPS
// FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN (except anti-stick and self-destruct)
// 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
// MEA - PUMP, INFUSION, PCA
// (except for combination products regulated under the InterCenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health, or the InterCenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.)
// FMF - SYRINGE, PISTON
// FLE - STERILIZER, STEAM
NEUROLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// GXW - ECHOENCEPHALOGRAPH
// GXY - ELECTRODE, CUTANEOUS
// GWQ - ELECTROENCEPHALOGRAPH
// GWG - ENDOSCOPE, NEUROLOGICAL
// GZJ - STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
OBSTETRICS AND GYNECOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// HIH - HYSTEROSCOPE (AND ACCESSORIES)
// HET - LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
// HEN - CALIPER, FETAL HEAD, ULTRASONIC
// HHX - HOLOGRAPH, FETAL ACOUSTICAL
// HEM - IMAGER, ULTRASONIC OBSTETRIC-GYNECOLOGIC
// HHJ - LOCATOR, INTRACORPOREAL DEVICE, ULTRASONIC
// HEP - MONITOR, BLOOD-FLOW, ULTRASONIC
// HEL - MONITOR, HEART RATE, FETAL, ULTRASONIC
// HEK - MONITOR, HEART SOUND, FETAL, ULTRASONIC
// HEI - MONITOR, HEART-VALVE MOVEMENT, FETAL, ULTRASONIC
// HEJ - MONITOR, HEMIC SOUND, ULTRASONIC
// HEQ - MONITOR, PRESSURE, ARTERIAL, FETAL, ULTRASONIC
// KNG - MONITOR, ULTRASONIC, FETAL
// HGL - TRANSDUCER, ULTRASONIC, OBSTETRIC
// HIS - CONDOM
OPHTHALMOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
HLI - OPHTHALMOSCOPE, AC-POWERED
HLJ - OPHTHALMOSCOPE, BATTERY-POWERED
HKL - RETINOSCOPE, AC-POWERED
HJO - BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
// 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
// HQC - UNIT, PHACOFRAGMENTATION
ORTHOPEDIC PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// HRX - ARTHROSCOPE AND ACCESSORIES
RADIOLOGY PANEL
| SECTION | REGULATION |
| NO | PRODUCT CODE - DEVICE |
// LXE - DOPPLER, FETAL ULTRASOUND
// MAA - MONITOR, FETAL DOPPLER ULTRASOUND
MOS - COIL, MAGNETIC RESONANCE, SPECIALTY
LNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
LNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC
KPS - SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
// JWM - SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
KPT - CALIBRATOR, DOSE, RADIONUCLIDE
// JAF - MONITOR, ULTRASONIC, NONFETAL
// IYN - SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
// IYO - SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
// ITX - TRANSDUCER, ULTRASONIC, DIAGNOSTIC
// IZI - SYSTEM, X-RAY, ANGIOGRAPHIC
// IZS - APERTURE, RADIOGRAPHIC
// IZW - COLLIMATOR, AUTOMATIC, RADIOGRAPHIC
// IZX - COLLIMATOR, MANUAL, RADIOGRAPHIC
// IZT - CONE, RADIOGRAPHIC
// KPW - DEVICE, BEAM LIMITING, X-RAY, DIAGNOSTIC
// IZJ - CAMERA, X-RAY, FLUOROGRAPHIC, CINE OR SPOT
// IXK - SYSTEM, IMAGING, X-RAY, ELECTROSTATIC
// JAA - SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
// IXL - DEVICE, SPOT-FILM
// KPR - SYSTEM, X-RAY, STATIONARY
// IZL - SYSTEM, X-RAY, MOBILE
// IZF - SYSTEM, X-RAY, TOMOGRAPHIC
// JAK - SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
// HBK - CHAIR, PNEUMOENCEPHALOGRAPHIC
// IXA - CASSETTE, RADIOGRAPHIC FILM
// KPX - CHANGER, RADIOGRAPHIC FILM/CASSETTE
// IZP - PROGRAMMER, CHANGER, FILM/CASSETTE, RADIOGRAPHIC
// EGT - CONTROLLER, TEMPERATURE, RADIOGRAPHIC
// EGW - DRYER, FILM, RADIOGRAPHIC
// IXX - PROCESSOR, CINE FILM
// IXW - PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC
// EGY - PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
GENERAL AND PLASTIC SURGERY PANEL
| SECTION | REGULATION |
// GCJ - LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
// HAM - APPARATUS, ELECTROSURGICAL
// GEI - DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
// JOT - ELECTRODE, GEL, ELECTROSURGICAL
// DWG - ELECTROSURGICAL DEVICE
// BWA - UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES
HBI - ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
FTF - ILLUMINATOR, NON-REMOTE
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
JCX - APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
BTA - PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)