CELEX: 52000PC0350
Language: en
Date: 2000-06-30
Title: 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

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52000PC0350

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  /* COM/2000/0350 final */  

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(presented by the Commission)EXPLANATORY MEMORANDUMI. Background1. 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 [1] and entered into force on 1 December 1998.[1]   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 (OJ L 31, .04.02.1999, p. 1).2. Article 21(1) 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(3) 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.II Amendments to the Sectoral Annex for Telecommunications Equipment (TTE)4. Directive 1999/5/EC on radio equipment and telecommunications terminal equipment [2] was adopted on 9 March 1999 and will repeal directive 1998/13/EC [3] 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:[2]   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 (OJ L 91, 07.04.1999,p. 10).[3]   Directive 98/13/EC of the European Parliament and the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition thereof (OJ L 74, 12.03.1998, p. 1).- 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.III. Amendments to the Sectoral Annex for Electromagnetic Compatibility (EMC)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.IV. Amendments to the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)6. The US has noted that Article 1(3) 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(3) 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(3) 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 Devices7. 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 AmericaTHE 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 [4] and in particular Article 3(3) of that Decision,[4]   OJ L 31, .04.02.1999, p. 1Having 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:Article 1The 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.Article 2The 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.Article 3The Decision of the Joint Committee shall be published in the Official Journal once it has been adopted.Done at Brussels,For the CouncilThe PresidentANNEX1. Amendments to the Sectoral Annex for Telecommunications Equipment1. 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.2. Amendments to the Sectoral Annex for Electromagnetic Compatibility (EMC)1. In Section IV, under the "U.S." column, "Federal Aviation Administration (FAA)" is deleted.3. Amendments to the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)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."4. Amendments to the Sectoral Annex for Medical Devices1. Table 1 is deleted in its entirety and is replaced with the following text:TABLE 1Class I products requiring premarket evaluations in the United States, included in scope of product coverage at beginning of transition periodDENTAL PANELSECTION  //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME872.4200  //  DENTAL HANDPIECES AND ACCESSORIES//  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-POWERED872.6250  //  DENTAL CHAIR AND ACCESSORIES//  KLC - CHAIR WITH A UNIT872.6640  //  DENTAL OPERATIVE UNIT AND ACCESSORIES//  DYN - MOUTHPIECE, SALIVA EJECTOR//  EBR - UNIT, SUCTION OPERATORY//  EHZ - EVACUATOR, ORAL CAVITY//  EIA - UNIT, OPERATIVE DENTAL872.6710  //  BOILING WATER STERILIZER//  ECG - STERILIZER, BOILING WATER1.1. GASTROENTEROLOGY-UROLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME876.5160  //  UROLOGICAL CLAMPS FOR MALES//  FHA - CLAMP, PENILEGENERAL AND PLASTIC SURGERY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME878.4460  //  SURGEON'S GLOVES//  KGO - SURGEON'S GLOVES880.5090  //  LIQUID BANDAGE//  KMF - BANDAGE, LIQUIDGENERAL HOSPITALSECTION   //  REGULATION NAMENO  //  PRODUCT CODE - DEVICE NAME880.5680  //  PEDIATRIC POSITION HOLDER//  FRP - HOLDER, INFANT POSITION880.6250  //  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, VINYL880.6375  //  PATIENT LUBRICANT//  KMJ - LUBRICANT, PATIENT//  MMS - LUBRICANT, VAGINAL, PATIENT880.6760  //  PROTECTIVE RESTRAINT//  BRT - RESTRAINT, PATIENT, CONDUCTIVE//  FMQ - RESTRAINT, PROTECTIVENEUROLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME882.1030  //  ATAXIAGRAPH//  GWW - ATAXIAGRAPH882.1420  //  ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER//  GWS - ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL882.4060  //  VENTRICULAR CANNULA//  HCD - CANNULA, VENTRICULAR882.4545  //  SHUNT SYSTEM IMPLANTATION INSTRUMENT//  GYK - INSTRUMENT, SHUNT SYSTEM IMPLANTATIONOBSTETRICS AND GYNECOLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME884.2980  //  THERMOGRAPHIC SYSTEM//  LHQ - SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)884.2982  //  LIQUID CRYSTAL TELETHERMOGRAPHIC SYSTEM//  LHM - SYSTEM, TELETHERMOGRAPHIC, LIQUID CRYSTAL//  KYA - SYSTEM, TELETHERMOGRAPHIC, LIQUID CRYSTAL, NONPOWERED (ADJUNCTIVE USE)OPHTHALMOLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME886.4070  //  POWERED CORNEAL BURR//  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-POWERED886.4300  //  INTRAOCULAR LENS GUIDE//  KYB - LENS, GUIDE, INTRAOCULAR886.4370  //  KERATOME//  HNO - KERATOME, AC-POWERED//  HMY - KERATOME, BATTERY-POWEREDORTHOPEDIC PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME888.1500  //  GONIOMETER//  KQX - GONIOMETER, AC-POWEREDPHYSICAL MEDICINE PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME890.3850  //  MECHANICAL WHEELCHAIR//  LBE - STROLLER, ADAPTIVE//  IOR - WHEELCHAIR, MECHANICAL890.5710  //  HOT OR COLD DISPOSABLE PACK//  IMD - PACK, HOT OR COLD, DISPOSABLERADIOLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME892.1100  //  SCINTILLATION (GAMMA) CAMERA//  IYX - CAMERA, SCINTILLATION (GAMMA)892.1110  //  POSITRON CAMERA//  IZC - CAMERA, POSITRON2. Table 2 is deleted in its entirety and is replaced with the following text:TABLE 2Class 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 PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME868.5630   //  NEBULIZER//  CAF - NEBULIZER (DIRECT PATIENT INTERFACE)CARDIOVASCULAR PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME870.1120  //  BLOOD PRESSURE CUFFDXQ - CUFF, BLOOD-PRESSURE870.1130  //  NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-oscillometric)//  DXN - SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE870.2300  //  CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM)DRT - MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)870.2330  //  ECHOCARDIOGRAPH//  DXK - ECHOCARDIOGRAPH870.2340  //  ELECTROCARDIOGRAPHDPS - ELECTROCARDIOGRAPHMLC - MONITOR, ST SEGMENT (without alarm)870.2350  //  ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR//  DRW - ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH870.2360  //  ELECTROCARDIOGRAPH ELECTRODE//  DRX - ELECTRODE, ELECTROCARDIOGRAPH870.2370  //  ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER//  KRC - TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC870.2880  //  ULTRASONIC TRANSDUCER//  JOP - TRANSDUCER, ULTRASONICDENTAL PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME872.3060   //  GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE//  EJT - ALLOY, GOLD BASED, FOR CLINICAL USE//  EJS - ALLOY, PRECIOUS METAL, FOR CLINICAL USE872.3200  //  RESIN TOOTH BONDING AGENT//  KLE - AGENT, TOOTH BONDING, RESIN872.3275  //  DENTAL CEMENTEMA - CEMENT, DENTALEMB - ZINC OXIDE EUGENOL872.3660  //  IMPRESSION MATERIALELW - MATERIAL, IMPRESSION872.3690  //  TOOTH SHADE RESIN MATERIAL//  EBF - MATERIAL, TOOTH SHADE, RESIN872.3710  //  BASE METAL ALLOY//  EJH - METAL, BASEGASTROENTEROLOGY-UROLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME876.1075  //  GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT//  KNW - INSTRUMENT, BIOPSY//  FCF - INSTRUMENT, BIOPSY, MECHANICAL, GASTROINTESTINAL//  FCK - INSTRUMENT, BIOPSY, SUCTION//  FCI - PUNCH, BIOPSY//  FCG - SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY876.1500  //  ENDOSCOPE AND ACCESSORIES//  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//  FDW - ESOPHAGOSCOPE, RIGID, GASTRO-UROLOGY//  FDS - GASTROSCOPE, GASTRO-UROLOGY//  GCK - GASTROSCOPE, GENERAL & PLASTIC SURGERY//  FFS - ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE//  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//  FBP - TELESCOPE, RIGID, ENDOSCOPIC//  GCW - TRANSFORMER, ENDOSCOPE//  FGB - URETEROSCOPE//  FGC - URETHROSCOPE876.4500  //  MECHANICAL LITHOTRIPTER//  LQC - LITHOTRIPTER, BILIARY MECHANICAL//  FGK - TRIPSOR, STONE, BLADDER876.5010  //  BILIARY CATHETER AND ACCESSORIES (biliary stone dislodger only)//  LQR - DISLODGER, STONE, BILIARY876.5320  //  NONIMPLANTED ELECTRICAL CONTINENCE DEVICE//  KPI - STIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE)876.5665  //  WATER PURIFICATION SYSTEM FOR HEMODIALYSIS//  FIP - SUBSYSTEM, WATER PURIFICATIONGENERAL HOSPITALSECTION   //  REGULATION NAMENO  //  PRODUCT CODE - DEVICE NAME880.2910   //  CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier)//  FLL - THERMOMETER, ELECTRONIC, CLINICAL880.5400  //  NEONATAL INCUBATORFMZ - INCUBATOR, NEONATAL880.5410  //  NEONATAL TRANSPORT INCUBATORFPL - INCUBATOR, NEONATAL TRANSPORT880.5570   //  HYPODERMIC SINGLE LUMEN NEEDLE//  MMK - CONTAINER, SHARPS//  FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN (except anti-stick and self-destruct)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//  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.)880.5860  //  PISTON SYRINGE//  FMF - SYRINGE, PISTON880.6880  //  STEAM STERILIZER (greater than 2 cubic feet)//  FLE - STERILIZER, STEAMNEUROLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME882.1240  //  ECHOENCEPHALOGRAPH//  GXW - ECHOENCEPHALOGRAPH882.1320  //  CUTANEOUS ELECTRODE//  GXY - ELECTRODE, CUTANEOUS882.1400  //  ELECTROENCEPHALOGRAPH//  GWQ - ELECTROENCEPHALOGRAPH882.1480  //  NEUROLOGICAL ENDOSCOPE//  GWG - ENDOSCOPE, NEUROLOGICAL882.5890  //  TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF//  GZJ - STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEFOBSTETRICS AND GYNECOLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME884.1690  //  HYSTEROSCOPE AND ACCESSORIES//  HIH - HYSTEROSCOPE (AND ACCESSORIES)884.1720  //  GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES//  HET - LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)884.2225  //  OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER//  HEN - CALIPER, FETAL HEAD, ULTRASONIC//  HHX - HOLOGRAPH, FETAL ACOUSTICAL//  HEM - IMAGER, ULTRASONIC OBSTETRIC-GYNECOLOGIC//  HHJ - LOCATOR, INTRACORPOREAL DEVICE, ULTRASONIC884.2660  //  FETAL ULTRASONIC MONITOR AND ACCESSORIES//  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, FETAL884.2960  //  OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES//  HGL - TRANSDUCER, ULTRASONIC, OBSTETRIC884.5300  //  CONDOM//  HIS - CONDOMOPHTHALMOLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME886.1570  //  OPHTHALMOSCOPEHLI - OPHTHALMOSCOPE, AC-POWEREDHLJ - OPHTHALMOSCOPE, BATTERY-POWERED886.1780  //  RETINOSCOPEHKL - RETINOSCOPE, AC-POWERED886.1850  //  AC-POWERED SLIT-LAMP BIOMICROSCOPEHJO - BIOMICROSCOPE, SLIT-LAMP, AC-POWERED886.4150  //  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 CUTTER886.4670  //  PHACOFRAGMENTATION SYSTEM//  HQC - UNIT, PHACOFRAGMENTATIONORTHOPEDIC PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME888.1100  //  ARTHROSCOPE//  HRX - ARTHROSCOPE AND ACCESSORIESRADIOLOGY PANELSECTION   //  REGULATION NAMENO   //  PRODUCT CODE - DEVICE NAME884.2660  //  FETAL ULTRASONIC MONITOR AND ACCESSORIES//  LXE - DOPPLER, FETAL ULTRASOUND//  MAA - MONITOR, FETAL DOPPLER ULTRASOUND892.1000  //  MAGNETIC RESONANCE DIAGNOSTIC DEVICEMOS - COIL, MAGNETIC RESONANCE, SPECIALTYLNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGINGLNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC892.1200  //  EMISSION COMPUTED TOMOGRAPHY SYSTEMKPS - SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION892.1310  //  NUCLEAR TOMOGRAPHY SYSTEM//  JWM - SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION892.1360  //  RADIONUCLIDE DOSE CALIBRATORKPT - CALIBRATOR, DOSE, RADIONUCLIDE892.1540   //  NONFETAL ULTRASONIC MONITOR//  JAF - MONITOR, ULTRASONIC, NONFETAL892.1550   //  ULTRASONIC PULSED DOPPLER IMAGING SYSTEM//  IYN - SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC892.1560  //  ULTRASONIC PULSED ECHO IMAGING SYSTEM//  IYO - SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC892.1570  //  DIAGNOSTIC ULTRASONIC TRANSDUCER//  ITX - TRANSDUCER, ULTRASONIC, DIAGNOSTIC892.1600   //  ANGIOGRAPHIC X-RAY SYSTEM//  IZI - SYSTEM, X-RAY, ANGIOGRAPHIC892.1610  //  DIAGNOSTIC X-RAY BEAM LIMITING DEVICE//  IZS - APERTURE, RADIOGRAPHIC//  IZW - COLLIMATOR, AUTOMATIC, RADIOGRAPHIC//  IZX - COLLIMATOR, MANUAL, RADIOGRAPHIC//  IZT - CONE, RADIOGRAPHIC//  KPW - DEVICE, BEAM LIMITING, X-RAY, DIAGNOSTIC892.1620  //  CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA//  IZJ - CAMERA, X-RAY, FLUOROGRAPHIC, CINE OR SPOT892.1630  //  ELECTROSTATIC X-RAY IMAGING SYSTEM//  IXK - SYSTEM, IMAGING, X-RAY, ELECTROSTATIC892.1650   //  IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM (except solid state)//  JAA - SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED892.1670  //  SPOT FILM DEVICE//  IXL - DEVICE, SPOT-FILM892.1680  //  STATIONARY X-RAY SYSTEM//  KPR - SYSTEM, X-RAY, STATIONARY892.1720   //  MOBILE X-RAY SYSTEM//  IZL - SYSTEM, X-RAY, MOBILE892.1740   //  TOMOGRAPHIC X-RAY SYSTEM//  IZF - SYSTEM, X-RAY, TOMOGRAPHIC892.1750  //  COMPUTED TOMOGRAPHY X-RAY SYSTEM//  JAK - SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED892.1820  //  PNEUMOENCEPHALOGRAPHIC CHAIR//  HBK - CHAIR, PNEUMOENCEPHALOGRAPHIC892.1850  //  RADIOGRAPHIC FILM CASSETTE//  IXA - CASSETTE, RADIOGRAPHIC FILM892.1860  //  RADIOGRAPHIC FILM/CASSETTE CHANGER//  KPX - CHANGER, RADIOGRAPHIC FILM/CASSETTE892.1870  //  RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER//  IZP - PROGRAMMER, CHANGER, FILM/CASSETTE, RADIOGRAPHIC892.1900  //  AUTOMATIC RADIOGRAPHIC FILM PROCESSOR//  EGT - CONTROLLER, TEMPERATURE, RADIOGRAPHIC//  EGW - DRYER, FILM, RADIOGRAPHIC//  IXX - PROCESSOR, CINE FILM//  IXW - PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC//  EGY - PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALGENERAL AND PLASTIC SURGERY PANELSECTION   //  REGULATION NAME//  PRODUCT CODE - DEVICE NAME876.1500  //  ENDOSCOPE AND ACCESSORIES//  GCJ - LAPAROSCOPE, GENERAL AND PLASTIC SURGERY878.4400  //  ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES//  HAM - APPARATUS, ELECTROSURGICAL//  GEI - DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES//  JOS - ELECTRODE, ELECTROSURGICAL//  JOT - ELECTRODE, GEL, ELECTROSURGICAL//  DWG - ELECTROSURGICAL DEVICE//  BWA - UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES878.4580  //  SURGICAL LAMPHBI - ILLUMINATOR, FIBEROPTIC, SURGICAL FIELDFTF - ILLUMINATOR, NON-REMOTEFTG - ILLUMINATOR, REMOTEHJE - LAMP, FLUORESCEIN, AC-POWEREDFQP - LAMP, OPERATING-ROOMFTD - LAMP, SURGICALGBC - LAMP, SURGICAL, INCANDESCENTFTA - LIGHT, SURGICAL, ACCESSORIESFSZ - LIGHT, SURGICAL, CARRIERFSY - LIGHT, SURGICAL, CEILING MOUNTEDFSX - LIGHT, SURGICAL, CONNECTORFSW - LIGHT, SURGICAL, ENDOSCOPICFST - LIGHT, SURGICAL, FIBEROPTICFSS - LIGHT, SURGICAL, FLOOR STANDINGFSQ - LIGHT, SURGICAL, INSTRUMENT878.4780  //  POWERED SUCTION PUMPJCX - APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWEREDBTA - PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)