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party may perform an inspection on its
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.
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-
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)
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
(None) Dental Panel (21 CFR Part 872)
Karaya and Sodium Borate with or without Acacia Denture
Ear, Nose, and Throat Panel (21 CFR Part 874)
Short Increment Sensitivity Index (SISI) Adapter
Gastroenterology-Urology Panel (21 CFR Part 876)
Urological Clamp for Males
General Hospital Panel (21 CFR Part 880)
Neonatal Eye Pad
TABLE 1.-CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD1_Continued
Obstetrics and Gynecology Panel
(None) Ophthalmology Panel (21 CFR Part 886)
Orthopedic Panel (21 CFR Part 888)
Physical Medicine Panel (21 CFR Part 890)
Radiology Panel (21 CFR Part 892)
Scintillation (Gamma) Camera
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.
Product CodeDevice Name
JAG—Illuminator, Radiographic-Film, Explosion-Proof 892.1910
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
Introduction/Drainage Catheter and Accessories
GCB-Needle, Catheter 878.4320
Removable Skin Clip
FZQ/Clip, Removable (Skin) 878.4460
KGOSurgeon's Gloves 878.4680
Nonpowered, Single Patient, Portable Suction Apparatus
Removable Skin Staple
GDT—Staple, Removable (Skin) 878.4820
AC-Powered, Battery-Powered, and Pneumatically Pow
ered Surgical Instrument Motors and Accessories/Attach
HAB—Saw, Powered, and Accessories 878.4960
Air or AC-Powered Operating Table and Air or AC-Pow
ered Operating Chair & Accessories
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".