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
Date: 2000-06-30
Institutions: European Commission
Subjects: United States, agreement (EU), mutual recognition principle

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 30.06.2000
COM(2000) 350 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)

I.

1.

2.

3.

II

4.

1

2

3

EXPLANATORY MEMORANDUM

Background

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 19981 and entered into force on 1 December 1998.

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.

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.

Amendments to the Sectoral Annex for Telecommunications Equipment (TTE)

Directive 1999/5/EC on radio equipment
terminal
equipment2 was adopted on 9 March 1999 and will repeal directive 1998/13/EC3 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:

and telecommunications

–

–

–

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.

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).
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).
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).

2

III.

Amendments to the Sectoral Annex for Electromagnetic Compatibility (EMC)

5.

IV.

6.

V.

7.

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.

Amendments to the Sectoral Annex for Pharmaceutical Good Manufacturing
Practices (GMPs)

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.”

Amendments to the Sectoral Annex for Medical Devices

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.

3

8.

9.

10.

11.

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.

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.

For Table 2 the US also proposes to expand the scope of product coverage for class
II medical devices eligible for
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.

third party pre-market assessment under

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.

4

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 America4 and
in particular Article 3(3) of that Decision,

Having regard to the proposal from the Commission5,

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.

4

5

OJ L 31, .04.02.1999, p. 1

5

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 2

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.

1.

2.

3.

4.

2.

1.

3.

Amendments to the Sectoral Annex for Telecommunications Equipment

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"

In Section III, paragraph 2(c) “Directive 98/13/EC” is deleted and replaced with
"Directive 1999/5/EC".

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."

In Appendix I, "ACTE Approval Committee for Terminal Equipment", "ADLNB
Association of Designated Laboratories and Notified Bodies" and "CTR Common
Technical Regulations" are deleted.

Amendments to the Sectoral Annex for Electromagnetic Compatibility (EMC)

In Section IV, under the “U.S.” column, “Federal Aviation Administration (FAA)” is
deleted.

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:

6

“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.

1.

Amendments to the Sectoral Annex for Medical Devices

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

TABLE 1

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

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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 -
ENDOSCOPE

INSUFFLATOR,

AUTOMATIC

CARBON-DIOXIDE

FOR

FHX -
INSTRUMENT

JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL

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

16

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

- STIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-

KPI
IMPLANTABLE)

876.5665

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

FIP - SUBSYSTEM, WATER PURIFICATION

17

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

18

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

19

#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

20

886.4150

VITREOUS ASPIRATION AND CUTTING INSTRUMENT

MMC - DILATOR, EXPANSIVE IRIS (ACCESSORY)

HQE -
AC-POWERED

INSTRUMENT, VITREOUS ASPIRATION AND CUTTING,

HKP -
BATTERY-POWERED

INSTRUMENT, VITREOUS ASPIRATION AND CUTTING,

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

21

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

22

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

23

#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)

24