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 MEMORANDUM

I. Background

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 [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 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 [4] and in particular Article 3(3) of that Decision,

[4] OJ L 31, .04.02.1999, p. 1

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:

Article 1

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.

Article 2

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.

Article 3

The Decision of the Joint Committee shall be published in the Official Journal once it has been adopted.

Done at Brussels,

For the Council

The President

ANNEX

1. Amendments to the Sectoral Annex for Telecommunications Equipment

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.

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 Devices

1. Table 1 is deleted in its entirety and is replaced with the following text:

TABLE 1

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 NAME

NO // PRODUCT CODE - DEVICE NAME

872.4200 // 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-POWERED

872.6250 // DENTAL CHAIR AND ACCESSORIES

// KLC - CHAIR WITH A UNIT

872.6640 // DENTAL OPERATIVE UNIT AND ACCESSORIES

// DYN - MOUTHPIECE, SALIVA EJECTOR

// EBR - UNIT, SUCTION OPERATORY

// EHZ - EVACUATOR, ORAL CAVITY

// EIA - UNIT, OPERATIVE DENTAL

872.6710 // BOILING WATER STERILIZER

// ECG - STERILIZER, BOILING WATER

1.1. GASTROENTEROLOGY-UROLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

876.5160 // UROLOGICAL CLAMPS FOR MALES

// FHA - CLAMP, PENILE

GENERAL AND PLASTIC SURGERY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

878.4460 // SURGEON'S GLOVES

// KGO - SURGEON'S GLOVES

880.5090 // LIQUID BANDAGE

// KMF - BANDAGE, LIQUID

GENERAL HOSPITAL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

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

// MMS - LUBRICANT, VAGINAL, PATIENT

880.6760 // PROTECTIVE RESTRAINT

// BRT - RESTRAINT, PATIENT, CONDUCTIVE

// FMQ - RESTRAINT, PROTECTIVE

NEUROLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

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

OBSTETRICS AND GYNECOLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

884.2980 // 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 PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

886.4070 // 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-POWERED

886.4300 // INTRAOCULAR LENS GUIDE

// KYB - LENS, GUIDE, INTRAOCULAR

886.4370 // KERATOME

// HNO - KERATOME, AC-POWERED

// HMY - KERATOME, BATTERY-POWERED

ORTHOPEDIC PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

888.1500 // GONIOMETER

// KQX - GONIOMETER, AC-POWERED

PHYSICAL MEDICINE PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

890.3850 // MECHANICAL WHEELCHAIR

// LBE - STROLLER, ADAPTIVE

// IOR - WHEELCHAIR, MECHANICAL

890.5710 // HOT OR COLD DISPOSABLE PACK

// IMD - PACK, HOT OR COLD, DISPOSABLE

RADIOLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

892.1100 // SCINTILLATION (GAMMA) CAMERA

// IYX - CAMERA, SCINTILLATION (GAMMA)

892.1110 // POSITRON CAMERA

// IZC - CAMERA, POSITRON

2. Table 2 is deleted in its entirety and is replaced with the following text:

TABLE 2

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 NAME

NO // PRODUCT CODE - DEVICE NAME

868.5630 // NEBULIZER

// CAF - NEBULIZER (DIRECT PATIENT INTERFACE)

CARDIOVASCULAR PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

870.1120 // BLOOD PRESSURE CUFF

DXQ - CUFF, BLOOD-PRESSURE

870.1130 // NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-oscillometric)

// DXN - SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

870.2300 // CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM)

DRT - MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

870.2330 // ECHOCARDIOGRAPH

// DXK - ECHOCARDIOGRAPH

870.2340 // ELECTROCARDIOGRAPH

DPS - ELECTROCARDIOGRAPH

MLC - MONITOR, ST SEGMENT (without alarm)

870.2350 // ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR

// DRW - ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH

870.2360 // ELECTROCARDIOGRAPH ELECTRODE

// DRX - ELECTRODE, ELECTROCARDIOGRAPH

870.2370 // ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER

// KRC - TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC

870.2880 // ULTRASONIC TRANSDUCER

// JOP - TRANSDUCER, ULTRASONIC

DENTAL PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

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

872.3200 // RESIN TOOTH BONDING AGENT

// KLE - AGENT, TOOTH BONDING, RESIN

872.3275 // DENTAL CEMENT

EMA - CEMENT, DENTAL

EMB - ZINC OXIDE EUGENOL

872.3660 // IMPRESSION MATERIAL

ELW - MATERIAL, IMPRESSION

872.3690 // TOOTH SHADE RESIN MATERIAL

// EBF - MATERIAL, TOOTH SHADE, RESIN

872.3710 // BASE METAL ALLOY

// EJH - METAL, BASE

GASTROENTEROLOGY-UROLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

876.1075 // 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-UROLOGY

876.1500 // 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 - URETHROSCOPE

876.4500 // MECHANICAL LITHOTRIPTER

// LQC - LITHOTRIPTER, BILIARY MECHANICAL

// FGK - TRIPSOR, STONE, BLADDER

876.5010 // BILIARY CATHETER AND ACCESSORIES (biliary stone dislodger only)

// LQR - DISLODGER, STONE, BILIARY

876.5320 // NONIMPLANTED ELECTRICAL CONTINENCE DEVICE

// KPI - STIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE)

876.5665 // WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

// FIP - SUBSYSTEM, WATER PURIFICATION

GENERAL HOSPITAL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

880.2910 // CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier)

// FLL - THERMOMETER, ELECTRONIC, CLINICAL

880.5400 // NEONATAL INCUBATOR

FMZ - INCUBATOR, NEONATAL

880.5410 // NEONATAL TRANSPORT INCUBATOR

FPL - INCUBATOR, NEONATAL TRANSPORT

880.5570 // 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, PISTON

880.6880 // STEAM STERILIZER (greater than 2 cubic feet)

// FLE - STERILIZER, STEAM

NEUROLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

882.1240 // ECHOENCEPHALOGRAPH

// GXW - ECHOENCEPHALOGRAPH

882.1320 // CUTANEOUS ELECTRODE

// GXY - ELECTRODE, CUTANEOUS

882.1400 // ELECTROENCEPHALOGRAPH

// GWQ - ELECTROENCEPHALOGRAPH

882.1480 // NEUROLOGICAL ENDOSCOPE

// GWG - ENDOSCOPE, NEUROLOGICAL

882.5890 // TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF

// GZJ - STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

OBSTETRICS AND GYNECOLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

884.1690 // 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, ULTRASONIC

884.2660 // 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, FETAL

884.2960 // OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES

// HGL - TRANSDUCER, ULTRASONIC, OBSTETRIC

884.5300 // CONDOM

// HIS - CONDOM

OPHTHALMOLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

886.1570 // OPHTHALMOSCOPE

HLI - OPHTHALMOSCOPE, AC-POWERED

HLJ - OPHTHALMOSCOPE, BATTERY-POWERED

886.1780 // RETINOSCOPE

HKL - RETINOSCOPE, AC-POWERED

886.1850 // AC-POWERED SLIT-LAMP BIOMICROSCOPE

HJO - BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

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

886.4670 // PHACOFRAGMENTATION SYSTEM

// HQC - UNIT, PHACOFRAGMENTATION

ORTHOPEDIC PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

888.1100 // ARTHROSCOPE

// HRX - ARTHROSCOPE AND ACCESSORIES

RADIOLOGY PANEL

SECTION // REGULATION NAME

NO // PRODUCT CODE - DEVICE NAME

884.2660 // FETAL ULTRASONIC MONITOR AND ACCESSORIES

// LXE - DOPPLER, FETAL ULTRASOUND

// MAA - MONITOR, FETAL DOPPLER ULTRASOUND

892.1000 // MAGNETIC RESONANCE DIAGNOSTIC DEVICE

MOS - COIL, MAGNETIC RESONANCE, SPECIALTY

LNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

LNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC

892.1200 // EMISSION COMPUTED TOMOGRAPHY SYSTEM

KPS - SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

892.1310 // NUCLEAR TOMOGRAPHY SYSTEM

// JWM - SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

892.1360 // RADIONUCLIDE DOSE CALIBRATOR

KPT - CALIBRATOR, DOSE, RADIONUCLIDE

892.1540 // NONFETAL ULTRASONIC MONITOR

// JAF - MONITOR, ULTRASONIC, NONFETAL

892.1550 // ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

// IYN - SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

892.1560 // ULTRASONIC PULSED ECHO IMAGING SYSTEM

// IYO - SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

892.1570 // DIAGNOSTIC ULTRASONIC TRANSDUCER

// ITX - TRANSDUCER, ULTRASONIC, DIAGNOSTIC

892.1600 // ANGIOGRAPHIC X-RAY SYSTEM

// IZI - SYSTEM, X-RAY, ANGIOGRAPHIC

892.1610 // 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, DIAGNOSTIC

892.1620 // CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA

// IZJ - CAMERA, X-RAY, FLUOROGRAPHIC, CINE OR SPOT

892.1630 // ELECTROSTATIC X-RAY IMAGING SYSTEM

// IXK - SYSTEM, IMAGING, X-RAY, ELECTROSTATIC

892.1650 // IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM (except solid state)

// JAA - SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

892.1670 // SPOT FILM DEVICE

// IXL - DEVICE, SPOT-FILM

892.1680 // STATIONARY X-RAY SYSTEM

// KPR - SYSTEM, X-RAY, STATIONARY

892.1720 // MOBILE X-RAY SYSTEM

// IZL - SYSTEM, X-RAY, MOBILE

892.1740 // TOMOGRAPHIC X-RAY SYSTEM

// IZF - SYSTEM, X-RAY, TOMOGRAPHIC

892.1750 // COMPUTED TOMOGRAPHY X-RAY SYSTEM

// JAK - SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

892.1820 // PNEUMOENCEPHALOGRAPHIC CHAIR

// HBK - CHAIR, PNEUMOENCEPHALOGRAPHIC

892.1850 // RADIOGRAPHIC FILM CASSETTE

// IXA - CASSETTE, RADIOGRAPHIC FILM

892.1860 // RADIOGRAPHIC FILM/CASSETTE CHANGER

// KPX - CHANGER, RADIOGRAPHIC FILM/CASSETTE

892.1870 // RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER

// IZP - PROGRAMMER, CHANGER, FILM/CASSETTE, RADIOGRAPHIC

892.1900 // 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, DENTAL

GENERAL AND PLASTIC SURGERY PANEL

SECTION // REGULATION NAME

// PRODUCT CODE - DEVICE NAME

876.1500 // ENDOSCOPE AND ACCESSORIES

// GCJ - LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

878.4400 // 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 ACCESSORIES

878.4580 // SURGICAL LAMP

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

878.4780 // POWERED SUCTION PUMP

JCX - APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

BTA - PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)