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party may perform an inspection on its

own.

to all authorities and the Joint Committee described in subpart of this part;

(3) Providing a forum to discuss issues relating to this subpart, including concerns that a CAB may no longer be equivalent and opportunity to review product coverage; and

(4) Consideration of the issue of suspension.

$26.44 Transmission of product eval

uation reports. Transmission of product evaluation reports will take place according to the importing party's specified procedures. $ 26.45 Monitoring continued equiva

lence. Monitoring activities will be carried out in accordance with $26.69. § 26.46 Listing of additional CAB's.

(a) During the operational period, additional conformity assessment bodies (CAB's) will be considered for equivalence using the procedures and criteria described in 88 26.36, 26.37, and 26.39, taking into account the level of confidence gained in the overall regulatory system of the other party.

(b) Once a designating authority considers that such CAB's, having undergone the procedures of $826.36, 26.37, and 26.39, may be determined to be equivalent, it will then designate those bodies on an annual basis. Such procedures satisfy the procedures of $26.66(a) and (b).

(c) Following such annual designations, the procedures for confirmation of CAB's under $26.66(c) and (d) shall apply.

$26.48 Harmonization.

During both the transitional and operational phases of this subpart, both parties intend to continue to participate in the activities of the Global Harmonization Task Force (GHTF) and utilize the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the GHTF and jointly determining whether they are applicable to the implementation of this subpart.

$26.49 Regulatory cooperation.

(a) The parties and authorities shall inform and consult with one another, as permitted by law, of proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.

(b) The parties shall notify each other in writing of any changes to Appendix A of this subpart.

§ 26.47 Role and composition of the

Joint Sectoral Committee. (a) The Joint Sectoral Committee for this subpart is set up to monitor the activities under both the transitional and operational phases of this subpart.

(b) The Joint Sectoral Committee will be cochaired by a representative of the Food and Drug Administration (FDA) for the United States and a representative of the European Community (EC) who will each have one vote. Decisions will be taken by unanimous consent.

(c) The Joint Sectoral Committee's functions will include:

(1) Making a joint assessment of the equivalence of conformity assessment bodies (CAB's);

(2) Developing and maintaining the list of equivalent CAB's, including any limitation in terms of their scope of activities and communicating the list

$26.50 Alert system and exchange of

postmarket vigilance reports. (a) An alert system will be set up during the transition period and maintained thereafter by which the parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an Appendix F of this subpart. As part of that system, each party shall notify the other party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations.

(b) Contact points will be agreed between both parties to permit authorities to be made aware with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.

APPENDIX B TO SUBPART B OF PART 26

SCOPE OF PRODUCT COVERAGE

APPENDIX A TO SUBPART BOF PART 26

RELEVANT LEGISLATION, REGULA-
TIONS, AND PROCEDURES.

1. Initial Coverage of the Transition Period Upon entry into force of this subpart as described in $26.80 (it is understood that the date of entry into force will not occur prior to June 1, 1998, unless the parties decide otherwise), products qualifying for the transitional arrangements under this subpart include: a. All Class I products requiring premarket

evaluations in the United States-see

Table 1. b. Those Class II products listed in Table 2.

1. For the European Community (EC) the fol

lowing legislation applies to $26.42(a) of this subpart:

[Copies of EC documents may be obtained from the European Document Research, 1100 17th St. NW., suite 301, Washington, DC 20036.] a. Council Directive 90/385/EEC of 20 June 1990 on active implantable medical devices OJ No. L 189, 20.7. 1990, p. 17. Conformity

assessment procedures. Annex 2 (with the exception of section 4) Annex 4

Annex 5 b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ No. L 169,12.7.1993, p.1. Conformity assessment procedures.

Annex 2 (with the exception of section 4)
Annex 3
Annex 4
Annex 5
Annex 6

2. During the Transition Period The parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows: a. Those for which review may be based

primarily on written guidance which the parties will use their best efforts to pre

pare expeditiously; and b. Those for which review may be based

primarily on international standards, in order for the parties to gain the requisite

experience. The corresponding additional product lists will be phased in on an annual basis. The parties may consult with industry and other interested parties in determining which products will be added.

2. For the United States, the following

legislation applies to 8 26.32(a): [Copies of FDA documents may be obtained from the Government Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents may be viewed on FDA's Internet web site at “http://www.fda.gov”.] a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq. b. The Public Health Service Act, 42 U.S.C. 201 et seq. c. Regulations of the United States Food and Drug Administration found at 21 CFR, in particular, Parts 800 to 1299. d. Medical Devices; Third Party Review of Selected Premarket Notifications; Pilot Program, 61 FR 14789_14796 (April 3, 1996). e. Draft Guidance Document on Accredited Persons Program, 63 FR 28392 (May 22, 1998). f. Draft Guidance for Staff, Industry and Third Parties, Third Party Programs under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA), 63 FR 36240 (July 2, 1998). g. Guidance Document on Use of Standards, 63 FR 9561 (February 25, 1998).

3. Commencement of the Operational Period a. At the commencement of the oper

ational period, product coverage shall extend to all Class I/II products covered

during the transition period. b. FDA will expand the program to cat

egories of Class II devices as is consistent with the results of the pilot, and with FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third party review is available in the United States.

4. Unless explicitly included by joint deci

sion of the parties, this part does not cover any U.S. Class II-tier 3 or any Class III product under either system.

[The lists of medical devices included in these tables are subject to change as a result of the Food and Drug Administration Modernization Act of 1997.]

TABLE 1.-CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES,

INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1

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Cardiovascular Panel

(None) Dental Panel (21 CFR Part 872)

872.3400

872.3700

872.4200

Karaya and Sodium Borate with or without Acacia Denture

Adhesive
KOM—Adhesive, Denture, Acacia and Karaya With Sodium

Borate
Dental Mercury (U.S.P.)
ELY-Mercury
Dental Handpiece and Accessories
EBW-Controller, Food, Handpiece and Cord
EFB—Handpiece, Air-Powered, Dental
EFA—Handpiece, Belt and/or Gear Driven, Dental
EGS—Handpiece, Contra- and Right-Angle Attachment,

Dental
EKX-Handpiece, Direct Drive, AC-Powered
EKY-Handpiece, Water-Powered
Dental Operative Unit and Accessories
EIA—Unit, Operative Dental

872.6640

Ear, Nose, and Throat Panel (21 CFR Part 874)

874.1070

874.1500

874.1800

874.1925

874.3300

Short Increment Sensitivity Index (SISI) Adapter
ETR-Adapter, Short Increment Sensitivity Index (SISI)
Gustometer
ETM-Gustometer
Air or Water Caloric Stimulator
KHH-Stimulator, Caloric-Air
ETP_Stimulator, Caloric-Water
Toynbee Diagnostic Tube
ETK—Tube, Toynbee Diagnostic
Hearing Aid
LRB-Face Plate Hearing-Aid
ESD_Hearing-aid, Air-Conduction
Epistaxis Balloon
EMX–Balloon, Epistaxis
ENT Examination and Treatment Unit
ETF-Unit, Examining Treatment, ENT
Powered Nasal Irrigator
KMA—Irrigator, Powered Nasal
Antistammering Device
KTH-Device, Anti-Stammering

874.4100

874.5300

874.5550

874.5840

Gastroenterology-Urology Panel (21 CFR Part 876)

876.5160

876.5210

Urological Clamp for Males
FHA-Clamp, Penile
Enema Kit
FCE-Kit, Enema, (for Cleaning Purpose)
Urine Collector and Accessories
FAQ-Bag, Urine Collection, Leg, for External Use

876.5250

General Hospital Panel (21 CFR Part 880)

880.5270

880.5420

880.5680

Neonatal Eye Pad
FOK-Pad, Neonatal Eye
Pressure Infusor for an I.V. Bag
KZD—Infusor, Pressure, for I.V. Bags
Pediatric Position Holder
FRP-Holder, Infant Position
Patient Examination Glove
LZB-Finger Cot

880.6250

TABLE 1.-CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1_Continued

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Obstetrics and Gynecology Panel

(None) Ophthalmology Panel (21 CFR Part 886)

886.1780

886.1940

886.4070

Retinoscope
HKM—Retinoscope, Battery-Powered
Tonometer Sterilizer
HKZ-Sterilizer, Tonometer
Powered Corneal Burr
HQS—Burr, Corneal, AC-Powered
HOG-Burr, Corneal, Battery-Powered
HRG-Engine, Trephine, Accessories, AC-Powered
HFR-Engine, Trephine, Accessories, Battery-powered
HLD-Engine, Trephine, Accessories, Gas-Powered
Keratome
HNO—Keratome, AC-Powered
HMY-Keratome, Battery-Powered
Sunglasses (Nonprescription)
HQY—Sunglasses (Nonprescription Including Photosensi-

tive)

886.4370

886.5850

Orthopedic Panel (21 CFR Part 888)

888.1500

Goniometer
KQX-Goniometer, AC-Powered
Calipers for Clinical Use
KTZ-Caliper

888.4150

Physical Medicine Panel (21 CFR Part 890)

890.3850

890.5180

Mechanical Wheelchair
LBE—Stroller, Adaptive
IOR-Wheelchair, Mechanical
Manual Patient Rotation Bed
INY-Bed, Patient Rotation, Manual
Hot or Cold Disposable Pack
IMD-Pack, Hot or Cold, Disposable

890.5710

Radiology Panel (21 CFR Part 892)

892.1100

892.1110

892.1300

892.1320

Scintillation (Gamma) Camera
IYX-Camera, Scintillation (Gamma)
Positron Camera
IZC—Camera, Positron
Nuclear Rectilinear Scanner
IYW—Scanner, Rectilinear, Nuclear
Nuclear Uptake Probe
IZD-Probe, Uptake, Nuclear
Nuclear Whole Body Scanner
JAM-Scanner, Whole Body, Nuclear
Nuclear Electrocardiograph Synchronizer
IVY-Synchronizer, Electrocardiograph, Nuclear
Radiographic Film Illuminator
IXC—Illuminator, Radiographic-Film

892.1330

892.1410

892.1890

TABLE 1.-CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1—Continued

21 CFR Section No.

Regulation Name

Product CodeDevice Name

JAG—Illuminator, Radiographic-Film, Explosion-Proof 892.1910

Radiographic Grid

IXJ-Grid, Radiographic 892.1960

Radiographic Intensifying Screen

EAM—Screen, Intensifying, Radiographic 892.1970

Radiographic ECG/Respirator Synchronizer

IXO—Synchronizer, ECG/Respirator, Radiographic 892.5650

Manual Radionuclide Applicator System

IWG-System, Applicator, Radionuclide, Manual
General and Plastic Surgery Panel (21 CFR Part 878)
878.4200

Introduction/Drainage Catheter and Accessories
KGZ-Accessories, Catheter
GCE-Adaptor, Catheter
FGY-Cannula, Injection
GBA-Catheter, Balloon Type
GBZ-Catheter, Cholangiography
GBQ Catheter, Continuous Irrigation
GBY—Catheter, Eustachian, General & Plastic Surgery
JCY—Catheter, Infusion
GBX-Catheter, Irrigation
GBP—Catheter, Multiple Lumen
GBO—Catheter, Nephrostomy, General & Plastic Surgery
GBN—Catheter, Pediatric, General & Plastic Surgery
GBW—Catheter, Peritoneal
GBS—Catheter, Ventricular, General & Plastic Surgery
GCD-Connector, Catheter
GCC-Dilator, Catheter

GCB-Needle, Catheter 878.4320

Removable Skin Clip

FZQ/Clip, Removable (Skin) 878.4460

Surgeon's Gloves

KGOSurgeon's Gloves 878.4680

Nonpowered, Single Patient, Portable Suction Apparatus
GCY-Apparatus, Suction, Single Patient Use, Portable,

Nonpowered 878.4760

Removable Skin Staple

GDT—Staple, Removable (Skin) 878.4820

AC-Powered, Battery-Powered, and Pneumatically Pow

ered Surgical Instrument Motors and Accessories/Attach

ments
GFG-Bit, Surgical
GFA-Blade, Saw, General & Plastic Surgery
DWH—Blade, Saw, Surgical, Cardiovascular
BRZ—Board, Arm (With Cover)
GFE-Brush, Dermabrasion
GFF-Bur, Surgical, General & Plastic Surgery
KDG–Chisel (Osteotome)
GFDDermatome
GFC-Driver, Surgical, Pin
GFB—Head, Surgical, Hammer
GEY–Motor, Surgical Instrument, AC-Powered
GET—Motor, Surgical Instrument, Pneumatic Powered
DWI—Saw, Electrically Powered
KFK—Saw, Pneumatically Powered

HAB—Saw, Powered, and Accessories 878.4960

Air or AC-Powered Operating Table and Air or AC-Pow

ered Operating Chair & Accessories
GBB_Chair, Surgical, AC-Powered
FQO—Table, Operating-Room, AC-Powered
GDC-Table, Operating-rRoom, Electrical
FWW-Table, Operating-Room, Pneumatic
JEA–Table, Surgical with Orthopedic Accessories, AC-

Powered 880.5090

Liquid Bandage

KMF-Bandage, Liquid Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at "http://www.fda.gov/cdrh/prodcode.html".

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