Title 21: Food and Drugs
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PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Section Contents
§ 26.0 General.
Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
§ 26.1 Definitions.
§ 26.2 Purpose.
§ 26.3 Scope.
§ 26.4 Product coverage.
§ 26.5 Length of transition period.
§ 26.6 Equivalence assessment.
§ 26.7 Participation in the equivalence assessment and determination.
§ 26.8 Other transition activities.
§ 26.9 Equivalence determination.
§ 26.10 Regulatory authorities not listed as currently equivalent.
§ 26.11 Start of operational period.
§ 26.12 Nature of recognition of inspection reports.
§ 26.13 Transmission of postapproval inspection reports.
§ 26.14 Transmission of preapproval inspection reports.
§ 26.15 Monitoring continued equivalence.
§ 26.16 Suspension.
§ 26.17 Role and composition of the Joint Sectoral Committee.
§ 26.18 Regulatory collaboration.
§ 26.19 Information relating to quality aspects.
§ 26.20 Alert system.
§ 26.21 Safeguard clause.
Appendix A to Subpart A of Part 26—List of Applicable Laws, Regulations, and Administrative Provisions
Appendix B to Subpart A of Part 26—List of Authorities
Appendix C to Subpart A of Part 26—Indicative List of Products Covered by Subpart A
Appendix D to Subpart A of Part 26—Criteria for Assessing Equivalence for Post- and Preapproval
Appendix E to Subpart A of Part 26—Elements To Be Considered in Developing a Two-Way Alert System
Subpart B—Specific Sector Provisions for Medical Devices
§ 26.31 Purpose.
§ 26.32 Scope.
§ 26.33 Product coverage.
§ 26.34 Regulatory authorities.
§ 26.35 Length and purpose of transition period.
§ 26.36 Listing of CAB's.
§ 26.37 Confidence building activities.
§ 26.38 Other transition period activities.
§ 26.39 Equivalence assessment.
§ 26.40 Start of the operational period.
§ 26.41 Exchange and endorsement of quality system evaluation reports.
§ 26.42 Exchange and endorsement of product evaluation reports.
§ 26.43 Transmission of quality system evaluation reports.
§ 26.44 Transmission of product evaluation reports.
§ 26.45 Monitoring continued equivalence.
§ 26.46 Listing of additional CAB's.
§ 26.47 Role and composition of the Joint Sectoral Committee.
§ 26.48 Harmonization.
§ 26.49 Regulatory cooperation.
§ 26.50 Alert system and exchange of postmarket vigilance reports.
Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.
Appendix B to Subpart B of Part 26—Scope of Product Coverage
Appendixes C–F to Subpart B of Part 26 [Reserved]
Subpart C—“Framework” Provisions
§ 26.60 Definitions.
§ 26.61 Purpose of this part.
§ 26.62 General obligations.
§ 26.63 General coverage of this part.
§ 26.64 Transitional arrangements.
§ 26.65 Designating authorities.
§ 26.66 Designation and listing procedures.
§ 26.67 Suspension of listed conformity assessment bodies.
§ 26.68 Withdrawal of listed conformity assessment bodies.
§ 26.69 Monitoring of conformity assessment bodies.
§ 26.70 Conformity assessment bodies.
§ 26.71 Exchange of information.
§ 26.72 Sectoral contact points.
§ 26.73 Joint Committee.
§ 26.74 Preservation of regulatory authority.
§ 26.75 Suspension of recognition obligations.
§ 26.76 Confidentiality.
§ 26.77 Fees.
§ 26.78 Agreements with other countries.
§ 26.79 Territorial application.
§ 26.80 Entry into force, amendment, and termination.
§ 26.81 Final provisions.
Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.
Source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.
§ 26.0 General.
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This part substantially reflects relevant provisions of the framework agreement and its sectoral annexes on pharmaceutical good manufacturing practices (GMP's) and medical devices of the “Agreement on Mutual Recognition Between the United States of America and the European Community” (the MRA), signed at London May 18, 1998. For codification purposes, certain provisions of the MRA have been modified for use in this part. This modification is done for purposes of clarity only and shall not affect the text of the MRA concluded between the United States and the European Community (EC), or the rights and obligations of the United States or the EC under that agreement. Whereas the parties to the MRA are the United States and EC, this part is relevant only to the Food and Drug Administration's (FDA's) implementation of the MRA, including the sectoral annexes reflected in subparts A and B of this part. This part does not govern implementation of the MRA by the EC, which will implement the MRA in accordance with its internal procedures, nor does this part address implementation of the MRA by other concerned U.S. Federal agencies. For purposes of this part, the terms “party” or “parties,” where relevant to FDA's implementation of the MRA, should be considered as referring to FDA only. If the parties to the MRA subsequently amend or terminate the MRA, FDA will modify this part accordingly, using appropriate administrative procedures.
Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
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§ 26.1 Definitions.
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(a) Enforcement means action taken by an authority to protect the public from products of suspect quality, safety, and effectiveness or to assure that products are manufactured in compliance with appropriate laws, regulations, standards, and commitments made as part of the approval to market a product.
(b) Equivalence of the regulatory systems means that the systems are sufficiently comparable to assure that the process of inspection and the ensuing inspection reports will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled. Equivalence does not require that the respective regulatory systems have identical procedures.
(c) Good Manufacturing Practices (GMP's). [The United States has clarified its interpretation that under the MRA, paragraph (c)(1) of this section has to be understood as the U.S. definition and paragraph (c)(2) as the EC definition.]
(1) GMP's mean the requirements found in the legislations, 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.
(2) GMP's are that part of quality assurance which ensures that products are consistently produced and controlled to quality standards. For the purpose of this subpart, GMP's include, therefore, the system whereby the manufacturer receives the specifications of the product and/or process from the marketing authorization/product authorization or license holder or applicant and ensures the product is made in compliance with its specifications (qualified person certification in the EC).
(d) Inspection means an onsite evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with GMP's and/or commitments made as part of the approval to market a product.
(e) Inspection report means the written observations and GMP's compliance assessment completed by an authority listed in Appendix B of this subpart.
(f) Regulatory system means the body of legal requirements for GMP's, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements.
[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]
§ 26.2 Purpose.
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The provisions of this subpart govern the exchange between the parties and normal endorsement by the receiving regulatory authority of official good manufacturing practices (GMP's) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the parties, which is the cornerstone of this subpart.
§ 26.3 Scope.
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(a) The provisions of this subpart shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community (EC) before products are marketed (hereafter referred to as “preapproval inspections”) as well as during their marketing (hereafter referred to as “postapproval inspections”).
(b) Appendix A of this subpart names the laws, regulations, and administrative provisions governing these inspections and the good manufacturing practices (GMP's) requirements.
(c) Appendix B of this subpart lists the authorities participating in activities under this subpart.
(d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of subpart C of this part do not apply to this subpart.
§ 26.4 Product coverage.
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(a) The provisions of this subpart will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the European Community (EC)) and to drugs for human or animal use, biological products for human use, and active pharmaceutical ingredients (as referred to in the United States), only to the extent they are regulated by the authorities of both parties as listed in Appendix B of this subpart.
(b) Human blood, human plasma, human tissues and organs, and veterinary immunologicals (under 9 CFR 101.2, “veterinary immunologicals” are referred to as “veterinary biologicals”) are excluded from the scope of this subpart. Human plasma derivatives (such as immunoglobulins and albumin), investigational medicinal products/new drugs, human radiopharmaceuticals, and medicinal gases are also excluded during the transition phase; their situation will be reconsidered at the end of the transition period. Products regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research as devices are not covered under this subpart.
(c) Appendix C of this subpart contains an indicative list of products covered by this subpart.
[63 FR 60141, Nov. 6, 1998, as amended at 70 FR 14980, Mar. 24, 2005]
§ 26.5 Length of transition period.
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A 3-year transition period will start immediately after the effective date described in §26.80(a).
§ 26.6 Equivalence assessment.
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(a) The criteria to be used by the parties to assess equivalence are listed in Appendix D of this subpart. Information pertaining to the criteria under European Community (EC) competence will be provided by the EC.
(b) The authorities of the parties will establish and communicate to each other their draft programs for assessing the equivalence of the respective regulatory systems in terms of quality assurance of the products and consumer protection. These programs will be carried out, as deemed necessary by the regulatory authorities, for post- and preapproval inspections and for various product classes or processes.
(c) The equivalence assessment shall include information exchanges (including inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems and the authorities' capabilities. In conducting the equivalence assessment, the parties will ensure that efforts are made to save resources.
(d) Equivalence assessment for authorities added to Appendix B of this subpart after the effective date described in §26.80(a) will be conducted as described in this subpart, as soon as practicable.
§ 26.7 Participation in the equivalence assessment and determination.
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The authorities listed in Appendix B of this subpart will actively participate in these programs to build a sufficient body of evidence for their equivalence determination. Both parties will exercise good faith efforts to complete equivalence assessment as expeditiously as possible to the extent the resources of the authorities allow.
§ 26.8 Other transition activities.
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As soon as possible, the authorities will jointly determine the essential information which must be present in inspection reports and will cooperate to develop mutually agreed inspection report format(s).
§ 26.9 Equivalence determination.
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(a) Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix D of this subpart, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e.g., postapproval or preapproval) or product classes or processes.
(b) The parties will document insufficient evidence of equivalence, lack of opportunity to assess equivalence or a determination of nonequivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.
§ 26.10 Regulatory authorities not listed as currently equivalent.
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Authorities not currently listed as equivalent, or not equivalent for certain types of inspections, product classes or processes may apply for reconsideration of their status once the necessary corrective measures have been taken or additional experience is gained.
§ 26.11 Start of operational period.
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(a) The operational period shall start at the end of the transition period and its provisions apply to inspection reports generated by authorities listed as equivalent for the inspections performed in their territory.
(b) In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the Food and Drug Administration (FDA) will accept for normal endorsement (as provided in §26.12) inspection reports generated as a result of inspections conducted jointly by that authority on its territory and another authority listed as equivalent, provided that the authority of the Member State in which the inspection is performed can guarantee enforcement of the findings of the inspection report and require that corrective measures be taken when necessary. FDA has the option to participate in these inspections, and based on experience gained during the transition period, the parties will agree on procedures for exercising this option.
(c) In the European Community (EC), the qualified person will be relieved of responsibility for carrying the controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix A of this subpart) provided that these controls have been carried out in the United States and that each batch/lot is accompanied by a batch certificate (in accordance with the World Health Organization Certification Scheme on the Quality of Medicinal Products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.
§ 26.12 Nature of recognition of inspection reports.
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(a) Inspection reports (containing information as established under §26.8), including a good manufacturing practice (GMP) compliance assessment, prepared by authorities listed as equivalent, will be provided to the authority of the importing party. Based on the determination of equivalence in light of the experience gained, these inspection reports will normally be endorsed by the authority of the importing party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in an inspection report, quality defects identified in the postmarket surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the authority of the importing party may request clarification from the authority of the exporting party which may lead to a request for reinspection. The authorities will endeavor to respond to requests for clarification in a timely manner.
(b) Where divergence is not clarified in this process, an authority of the importing country may carry out an inspection of the production facility.
§ 26.13 Transmission of postapproval inspection reports.
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Postapproval good manufacturing practice (GMP) inspection reports concerning products covered by this subpart will be transmitted to the authority of the importing country within 60-calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted within 90-calendar days of the request.
§ 26.14 Transmission of preapproval inspection reports.
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(a) A preliminary notification that an inspection may have to take place will be made as soon as possible.
(b) Within 15-calendar days, the relevant authority will acknowledge receipt of the request and confirm its ability to carry out the inspection. In the European Community (EC), requests will be sent directly to the relevant authority, with a copy to the European Agency for the Evaluation of Medicinal Products (EMEA). If the authority receiving the request cannot carry out the inspection as requested, the requesting authority shall have the right to conduct the inspection.
(c) Reports of preapproval inspections will be sent within 45-calendar days of the request that transmitted the appropriate information and detailed the precise issues to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request.
§ 26.15 Monitoring continued equivalence.
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Monitoring activities for the purpose of maintaining equivalence shall include review of the exchange of inspection reports and their quality and timeliness; performance of a limited number of joint inspections; and the conduct of common training sessions.
§ 26.16 Suspension.
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(a) Each party has the right to contest the equivalence of a regulatory authority. This right will be exercised in an objective and reasoned manner in writing to the other party.
(b) The issue shall be discussed in the Joint Sectoral Committee promptly upon such notification. Where the Joint Sectoral Committee determines that verification of equivalence is required, it may be carried out jointly by the parties in a timely manner, under §26.6.
(c) Efforts will be made by the Joint Sectoral Committee to reach unanimous consent on the appropriate action. If agreement to suspend is reached in the Joint Sectoral Committee, an authority may be suspended immediately thereafter. If no agreement is reached in the Joint Sectoral Committee, the matter is referred to the Joint Committee as described in §26.73. If no unanimous consent is reached within 30 days after such notification, the contested authority will be suspended.
(d) Upon the suspension of authority previously listed as equivalent, a party is no longer obligated to normally endorse the inspection reports of the suspended authority. A party shall continue to normally endorse the inspection reports of that authority prior to suspension, unless the authority of the receiving party decides otherwise based on health or safety considerations. The suspension will remain in effect until unanimous consent has been reached by the parties on the future status of that authority.
§ 26.17 Role and composition of the Joint Sectoral Committee.
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(a) A Joint Sectoral Committee 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 each will have one vote. Decisions will be taken by unanimous consent.
(c) The Joint Sectoral Committee's functions will include:
(1) Making a joint assessment, which must be agreed by both parties, of the equivalence of the respective authorities;
(2) Developing and maintaining the list of equivalent authorities, including any limitation in terms of inspecting type or products, and communicating the list to all authorities and the Joint Committee;
(3) Providing a forum to discuss issues relating to this subpart, including concerns that an authority may be no longer equivalent and opportunity to review product coverage; and
(4) Consideration of the issue of suspension.
(d) The Joint Sectoral Committee shall meet at the request of either party and, unless the cochairs otherwise agree, at least once each year. The Joint Committee will be kept informed of the agenda and conclusions of meetings of the Joint Sectoral Committee.
§ 26.18 Regulatory collaboration.
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(a) The parties and authorities shall inform and consult one another, as permitted by law, on 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 B of this subpart.
§ 26.19 Information relating to quality aspects.
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The authorities will establish an appropriate means of exchanging information on any confirmed problem reports, corrective actions, recalls, rejected import consignments, and other regulatory and enforcement problems for products subject to this subpart.
§ 26.20 Alert system.
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(a) The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be considered in developing such a system are described in Appendix E of this subpart.
(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, recalls, counterfeiting, and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.
§ 26.21 Safeguard clause.
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Each party recognizes that the importing country has a right to fulfill its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in §26.12.
Appendix A to Subpart A of Part 26—List of Applicable Laws, Regulations, and Administrative Provisions
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1. For the European Community (EC):
[Copies of EC documents may be obtained from the European Document Research, 1100 17th St. NW., suite 301, Washington, DC 20036. EC documents may be viewed on the European Commission Pharmaceuticals Units web site at http://dg3.eudra.org.]
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation, or administrative action relating to proprietary medicinal products as extended, widened, and amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended.
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use.
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
Council Regulation EEC No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use.
Guide to Good Distribution Practice (94/C 63/03).
Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV.
2. For the United States:
[Copies of FDA documents may be obtained from the Government Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents, except the FDA Compliance Program Guidance Manual, may be viewed on FDA's Internet web site at http://www.fda.gov.]
Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 1–99, Parts 200–299, Parts 500–599, and Parts 600–799.
Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances.
Appendix B to Subpart A of Part 26—List of Authorities
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1. For the United States: In the United States, the regulatory authority is the Food and Drug Administration.
2. For the European Community: In the European Community, the regulatory authorities are the following:
Belgium: Inspection générale de la Pharmacie, Algemene Farmaceutische Inspectie.
Denmark: Laegemiddelstyrelsen.
Germany: Bundesministerium für Gesundheit for immunologicals: Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines.
Greece: Εθνικως Ωργανισμως Φαρμακωυ, Ministry of Health and Welfare, National Drug Organization (E.O.F).
Spain: For medicinal products for human use: Ministerio de Sanidad y Consumo, Subdirección General de Control Farmacéutico. For medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA), Dirección General de la Producción Agraria.
France: For medicinal products for human use: Agence du Médicament. For veterinary medicinal products: Agence Nationale du Médicament Vétérinaire.
Ireland: Irish Medicines Board.
Italy: For medicinal products for human use: Ministero della Sanità, Dipartimento Farmaci e Farmacovigilanza. For medicinal products for veterinary use: Ministero della Sanità, Dipartimento alimenti e nutrizione e sanità pubblica veterinaria-Div. IX.
Luxembourg: Division de la Pharmacie et des Médicaments.
Netherlands: Staat der Nederlanden.
Austria: Bundesministerium für Arbeit, Gesundheit und Soziales.
Portugal: Instituto da Farmácia e do Medicamento (INFARMED).
Finland: Lääkelaitos/Läkemedelsverket (National Agency for Medicines).
Sweden: Läkemedelsverket-Medical Products Agency.
United Kingdom: For human use and veterinary (non-immunologicals): Medicines Control Agency. For veterinary immunologicals: Veterinary Medicines Directorate.
European Community: Commission of the European Communities. European Agency for the Evaluation of Medicinal Products (EMEA).
Appendix C to Subpart A of Part 26—Indicative List of Products Covered by Subpart A
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Recognizing that precise definition of medicinal products and drugs are to be found in the legislation referred to above, an indicative list of products covered by this arrangement is given below:
—human medicinal products including prescription and nonprescription drugs;
—human biologicals including vaccines, and immunologicals;
—veterinary pharmaceuticals, including prescription and nonprescription drugs, with the exclusion of veterinary immunologicals (Under 9 CFR 101.2 “veterinary immunologicals” are referred to as “veterinary biologicals”);
—premixes for the preparation of veterinary medicated feeds (EC), Type A medicated articles for the preparation of veterinary medicated feeds (United States);
—intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting materials (EC).
Appendix D to Subpart A of Part 26—Criteria for Assessing Equivalence for Post- and Preapproval
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I. Legal/Regulatory authority and structures and procedures providing for post- and preapproval:
A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and guidance documents.
C. Authority to make inspections, review and copy documents, and to take samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information relating to matters covered by subpart A of this part.
II. Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest.
III. Administration of the regulatory authority:
A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate job performance.
C. Appropriate staffing and resources to enforce laws and regulations.
IV. Conduct of inspections:
A. Adequate preinspection preparation, including appropriate expertise of investigator/team, review of firm/product and databases, and availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to facilities, effective response to refusals, depth and competence of evaluation of operations, systems and documentation; collection of evidence; appropriate duration of inspection and completeness of written report of observations to firm management.
C. Adequate postinspection activities, including completeness of inspectors' report, inspection report review where appropriate, and conduct of followup inspections and other activities where appropriate, assurance of preservation and retrieval of records.
V. Execution of regulatory enforcement actions to achieve corrections, designed to prevent future violations, and to remove products found in violation of requirements from the market.
VI. Effective use of surveillance systems:
A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to marketing authorizations/approved applications.
VII. Additional specific criteria for preapproval inspections:
A. Satisfactory demonstration through a jointly developed and administered training program and joint inspections to assess the regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate records, including site plans and drug master file or similar documentation to enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches.
E. Ability to verify conformity of the onsite processes and procedures with those described in the application.
F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation.
Appendix E to Subpart A of Part 26—Elements To Be Considered in Developing a Two-Way Alert System
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1. Documentation
—Definition of a crisis/emergency and under what circumstances an alert is required
—Standard Operating Procedures (SOP's)
—Mechanism of health hazards evaluation and classification
—Language of communication and transmission of information
2. Crisis Management System
—Crisis analysis and communication mechanisms
—Establishment of contact points
—Reporting mechanisms
3. Enforcement Procedures
—Followup mechanisms
—Corrective action procedures
4. Quality Assurance System
—Pharmacovigilance programme
—Surveillance/monitoring of implementation of corrective action
5. Contact Points
For the purpose of subpart A of this part, the contact points for the alert system will be:
A. For the European Community:
the Executive Director of the European Agency for the Evaluation of Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14 4HB, England. Telephone 44–171–418 8400, Fax 418–8416.
B. For the United States :
Biologics: Director, Office of Compliance and Biologics Quality (HFM–600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301–827–6190, fax: 301–594-1944.
Human Drugs: Director, Office of Compliance (HFD–300), 5600 Fishers Lane, Rockville, MD 20857, phone: 301–827–8910, fax: 301–827–8901.
Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV–200), MPN II, 7500 Standish Pl., Rockville, MD 20855–2773, phone: 301–827–6644, fax: 301–594–1807.
[63 FR 60141, Nov. 6, 1998, as amended at 69 FR 48775, Aug. 11, 2004]
Subpart B—Specific Sector Provisions for Medical Devices
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§ 26.31 Purpose.
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(a) The purpose of this subpart is to specify the conditions under which a party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the other party with regard to medical devices as conducted by listed conformity assessment bodies (CAB's) and to provide for other related cooperative activities.
(b) This subpart is intended to evolve as programs and policies of the parties evolve. The parties will review this subpart periodically, in order to assess progress and identify potential enhancements to this subpart as Food and Drug Administration (FDA) and European Community (EC) policies evolve over time.
§ 26.32 Scope.
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(a) The provisions of this subpart shall apply to the exchange and, where appropriate, endorsement of the following types of reports from conformity assessment bodies (CAB's) assessed to be equivalent:
(1) Under the U.S. system, surveillance/postmarket and initial/preapproval inspection reports;
(2) Under the U.S. system, premarket (510(k)) product evaluation reports;
(3) Under the European Community (EC) system, quality system evaluation reports; and
(4) Under the EC system, EC type examination and verification reports.
(b) Appendix A of this subpart names the legislation, regulations, and related procedures under which:
(1) Products are regulated as medical devices by each party;
(2) CAB's are designated and confirmed; and
(3) These reports are prepared.
(c) For purposes of this subpart, equivalence means that: CAB's in the EC are capable of conducting product and quality systems evaluations against U.S. regulatory requirements in a manner equivalent to those conducted by FDA; and CAB's in the United States are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CAB's.
§ 26.33 Product coverage.
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(a) There are three components to this subpart each covering a discrete range of products:
(1) Quality System Evaluations. U.S.-type surveillance/postmarket and initial/preapproval inspection reports and European Community (EC)-type quality system evaluation reports will be exchanged with regard to all products regulated under both U.S. and EC law as medical devices.
(2) Product Evaluation. U.S.-type premarket (510(k)) product evaluation reports and EC-type-testing reports will be exchanged only with regard to those products classified under the U.S. system as Class I/Class II-Tier 2 medical devices which are listed in Appendix B of this subpart.
(3) Postmarket Vigilance Reports. Postmarket vigilance reports will be exchanged with regard to all products regulated under both U.S. and EC law as medical devices.
(b) Additional products and procedures may be made subject to this subpart by agreement of the parties.
§ 26.34 Regulatory authorities.
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The regulatory authorities shall have the responsibility of implementing the provisions of this subpart, including the designation and monitoring of conformity assessment bodies (CAB's). Regulatory authorities will be specified in Appendix C of this subpart. Each party will promptly notify the other party in writing of any change in the regulatory authority for a country.
§ 26.35 Length and purpose of transition period.
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There will be a 3-year transition period immediately following the date described in §26.80(a). During the transition period, the parties will engage in confidence-building activities for the purpose of obtaining sufficient evidence to make determinations concerning the equivalence of conformity assessment bodies (CAB's) of the other party with respect to the ability to perform quality system and product evaluations or other reviews resulting in reports to be exchanged under this subpart.
§ 26.36 Listing of CAB's.
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Each party shall designate conformity assessment bodies (CAB's) to participate in confidence building activities by transmitting to the other party a list of CAB's which meet the criteria for technical competence and independence, as identified in Appendix A of this subpart. The list shall be accompanied by supporting evidence. Designated CAB's will be listed in Appendix D of this subpart for participation in the confidence building activities once confirmed by the importing party. Nonconfirmation would have to be justified based on documented evidence.
§ 26.37 Confidence building activities.
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(a) At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building program calculated to provide sufficient evidence of the capabilities of the designated conformity assessment bodies (CAB's) to perform quality system or product evaluations to the specifications of the parties.
(b) The joint confidence building program should include the following actions and activities:
(1) Seminars designed to inform the parties and CAB's about each party's regulatory system, procedures, and requirements;
(2) Workshops designed to provide the parties with information regarding requirements and procedures for the designation and surveillance of CAB's;
(3) Exchange of information about reports prepared during the transition period;
(4) Joint training exercises; and
(5) Observed inspections.
(c) During the transition period, any significant problem that is identified with a CAB may be the subject of cooperative activities, as resources allow and as agreed to by the regulatory authorities, aimed at resolving the problem.
(d) Both parties will exercise good faith efforts to complete the confidence building activities as expeditiously as possible to the extent that the resources of the parties allow.
(e) Both the parties will each prepare annual progress reports which will describe the confidence building activities undertaken during each year of the transition period. The form and content of the reports will be determined by the parties through the Joint Sectoral Committee.
§ 26.38 Other transition period activities.
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(a) During the transition period, the parties will jointly determine the necessary information which must be present in quality system and product evaluation reports.
(b) The parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e.g., inspections by the parties of the importing country) or suspension of the distribution of the product.
§ 26.39 Equivalence assessment.
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(a) In the final 6 months of the transition period, the parties shall proceed to a joint assessment of the equivalence of the conformity assessment bodies (CAB's) that participated in the confidence building activities. CAB's will be determined to be equivalent provided they have demonstrated proficiency through the submission of a sufficient number of adequate reports. CAB's may be determined to be equivalent with regard to the ability to perform any type of quality system or product evaluation covered by this subpart and with regard to any type of product covered by this subpart. The parties shall develop a list contained in Appendix E of this subpart of CAB's determined to be equivalent, which shall contain a full explanation of the scope of the equivalency determination, including any appropriate limitations, with regard to performing any type of quality system or product evaluation.
(b) The parties shall allow CAB's not listed for participation in this subpart, or listed for participation only as to certain types of evaluations, to apply for participation in this subpart once the necessary measures have been taken or sufficient experience has been gained, in accordance with §26.46.
(c) Decisions concerning the equivalence of CAB's must be agreed to by both parties.
§ 26.40 Start of the operational period.
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(a) The operational period will start at the end of the transition period after the parties have developed the list of conformity assessment bodies (CAB's) found to be equivalent. The provisions of §§26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will apply only with regard to listed CAB's and only to the extent of any specifications and limitations contained on the list with regard to a CAB.
(b) The operational period will apply to quality system evaluation reports and product evaluation reports generated by CAB's listed in accordance with this subpart for the evaluations performed in the respective territories of the parties, except if the parties agree otherwise.
§ 26.41 Exchange and endorsement of quality system evaluation reports.
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(a) Listed European Community (EC) conformity assessment bodies (CAB's) will provide FDA with reports of quality system evaluations, as follows:
(1) For preapproval quality system evaluations, EC CAB's will provide full reports; and
(2) For surveillance quality system evaluations, EC CAB's will provide abbreviated reports.
(b) Listed U.S. CAB's will provide to the EC Notified Body of the manufacturer's choice:
(1) Full reports of initial quality system evaluations;
(2) Abbreviated reports of quality systems surveillance audits.
(c) If the abbreviated reports do not provide sufficient information, the importing party may request additional clarification from the CAB.
(d) Based on the determination of equivalence in light of the experience gained, the quality system evaluation reports prepared by the CAB's listed as equivalent will normally be endorsed by the importing party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in postmarket surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing party may request clarification from the exporting party which may lead to a request for reinspection. The parties will endeavor to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing party may carry out the quality system evaluation.
§ 26.42 Exchange and endorsement of product evaluation reports.
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(a) European Community (EC) conformity assessment bodies (CAB's) listed for this purpose will, subject to the specifications and limitations on the list, provide to FDA 510(k) premarket notification assessment reports prepared to U.S. medical device requirements.
(b) U.S. CAB's will, subject to the specifications and limitations on the list, provide to the EC Notified Body of the manufacturer's choice, type examination, and verification reports prepared to EC medical device requirements.
(c) Based on the determination of equivalence in light of the experience gained, the product evaluation reports prepared by the CAB's listed as equivalent will normally be endorsed by the importing party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies, inadequacies, or incompleteness in a product evaluation report, or other specific evidence of serious concern in relation to product safety, performance, or quality. In such cases, the importing party may request clarification from the exporting party which may lead to a request for a reevaluation. The parties will endeavor to respond to requests for clarification in a timely manner. Endorsement remains the responsibility of the importing party.
§ 26.43 Transmission of quality system evaluation reports.
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Quality system evaluation reports covered by §26.41 concerning products covered by this subpart shall be transmitted to the importing party within 60-calendar days of a request by the importing party. Should a new inspection be requested, the time period shall be extended by an additional 30-calendar days. A party may request a new inspection, for cause, identified to the other party. If the exporting party cannot perform an inspection within a specified period of time, the importing party may perform an inspection on its own.
§ 26.44 Transmission of product evaluation reports.
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Transmission of product evaluation reports will take place according to the importing party's specified procedures.
§ 26.45 Monitoring continued equivalence.
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Monitoring activities will be carried out in accordance with §26.69.
§ 26.46 Listing of additional CAB's.
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(a) During the operational period, additional conformity assessment bodies (CAB's) will be considered for equivalence using the procedures and criteria described in §§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 §§26.36, 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.
§ 26.47 Role and composition of the Joint Sectoral Committee.
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(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 to all authorities and the Joint Committee described in subpart C 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.
§ 26.48 Harmonization.
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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.
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(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.
§ 26.50 Alert system and exchange of postmarket vigilance reports.
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(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 A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.
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1. For the European Community (EC) the following 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. For the United States, the following legislation applies to §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).
Appendix B to Subpart B of Part 26—Scope of Product Coverage
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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.
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 prepare 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.
3. Commencement of the Operational Period
a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period.
b. FDA will expand the program to categories 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 decision 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 UnitedStates, Included in Scope of Product Coverage at Beginning of Transition Period\1\------------------------------------------------------------------------ 21 CFR Section No. Regulation Name------------------------------------------------------------------------ Product Code_Device Name------------------------------------------------------------------------Anesthesiology Panel (21 CFR Part 868) 868.1910 Esophageal Stethoscope BZW_Stethoscope, Esophageal 868.5620 Breathing Mouthpiece BYP_Mouthpiece, Breathing 868.5640 Medicinal Nonventilatory Nebulizer (Atomizer) CCQ_Nebulizer, Medicinal, Nonventilatory (Atomizer) 868.5675 Rebreathing Device BYW_Device, Rebreathing 868.5700 Nonpowered Oxygen Tent FOG_Hood, Oxygen, Infant BYL_Tent, Oxygen 868.6810 Tracheobronchial Suction Catheter BSY_Catheters, Suction, TracheobronchialCardiovascular Panel (None)Dental Panel (21 CFR Part 872) 872.3400 Karaya and Sodium Borate With or Without Acacia Denture Adhesive KOM_Adhesive, Denture, Acacia and Karaya With Sodium Borate 872.3700 Dental Mercury (U.S.P.) ELY_Mercury 872.4200 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 872.6640 Dental Operative Unit and Accessories EIA_Unit, Operative DentalEar, Nose, and Throat Panel (21 CFR Part 874) 874.1070 Short Increment Sensitivity Index (SISI) Adapter ETR_Adapter, Short Increment Sensitivity Index (SISI) 874.1500 Gustometer ETM_Gustometer 874.1800 Air or Water Caloric Stimulator KHH_Stimulator, Caloric-Air ETP_Stimulator, Caloric-Water 874.1925 Toynbee Diagnostic Tube ETK_Tube, Toynbee Diagnostic 874.3300 Hearing Aid LRB_Face Plate Hearing-Aid ESD_Hearing-aid, Air-Conduction 874.4100 Epistaxis Balloon EMX_Balloon, Epistaxis 874.5300 ENT Examination and Treatment Unit ETF_Unit, Examining/Treatment, ENT 874.5550 Powered Nasal Irrigator KMA_Irrigator, Powered Nasal 874.5840 Antistammering Device KTH_Device, Anti-StammeringGastroenterology_Urology Panel (21 CFR Part 876) 876.5160 Urological Clamp for Males FHA_Clamp, Penile 876.5210 Enema Kit FCE_Kit, Enema, (for Cleaning Purpose) 876.5250 Urine Collector and Accessories FAQ_Bag, Urine Collection, Leg, for External UseGeneral Hospital Panel (21 CFR Part 880) 880.5270 Neonatal Eye Pad FOK_Pad, Neonatal Eye 880.5420 Pressure Infusor for an I.V. Bag KZD_Infusor, Pressure, for I.V. Bags 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 880.6760 Protective Restraint BRT_Restraint, Patient, Conductive FMQ_Restraint, ProtectiveNeurology Panel (21 CFR Part 882) 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 882.4650 Neurosurgical Suture Needle HAS_Needle, Neurosurgical Suture 882.4750 Skull Punch GXJ_Punch, SkullObstetrics and Gynecology Panel (None)Ophthalmology Panel (21 CFR Part 886) 886.1780 Retinoscope HKM_Retinoscope, Battery-Powered 886.1940 Tonometer Sterilizer HKZ_Sterilizer, Tonometer 886.4070 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 886.4370 Keratome HNO_Keratome, AC-Powered HMY_Keratome, Battery-Powered 886.5850 Sunglasses (Nonprescription) HQY_Sunglasses (Nonprescription Including Photosensitive)Orthopedic Panel (21 CFR Part 888) 888.1500 Goniometer KQX_Goniometer, AC-Powered 888.4150 Calipers for Clinical Use KTZ_CaliperPhysical Medicine Panel (21 CFR Part 890) 890.3850 Mechanical Wheelchair LBE_Stroller, Adaptive IOR_Wheelchair, Mechanical 890.5180 Manual Patient Rotation Bed INY_Bed, Patient Rotation, Manual 890.5710 Hot or Cold Disposable Pack IMD_Pack, Hot or Cold, DisposableRadiology Panel (21 CFR Part 892) 892.1100 Scintillation (Gamma) Camera IYX_Camera, Scintillation (Gamma) 892.1110 Positron Camera IZC_Camera, Positron 892.1300 Nuclear Rectilinear Scanner IYW_Scanner, Rectilinear, Nuclear 892.1320 Nuclear Uptake Probe IZD_Probe, Uptake, Nuclear 892.1330 Nuclear Whole Body Scanner JAM_Scanner, Whole Body, Nuclear 892.1410 Nuclear Electrocardiograph Synchronizer IVY_Synchronizer, Electrocardiograph, Nuclear 892.1890 Radiographic Film Illuminator IXC_Illuminator, Radiographic- Film 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, ManualGeneral 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 KGO_Surgeon'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 Powered Surgical Instrument Motors and Accessories/Attachments 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) GFD_Dermatome 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-Powered Operating Chair & Accessories GBB_Chair, Surgical, AC-Powered FQO_Table, Operating-Room, AC- Powered GDC_Table, Operating-Room, Electrical FWW_Table, Operating-Room, Pneumatic JEA_Table, Surgical with Orthopedic Accessories, AC- Powered 880.5090 Liquid Bandage KMF_Bandage, Liquid------------------------------------------------------------------------\1\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.php.
Table 2_Class II Medical Devices Included in Scope of Product Coverage at Beginning of Transition Period (United States to develop guidance documents identifying U.S. requirements and European Community (EC) to identify standards needed to meet EC requirements)\1\------------------------------------------------------------------------ Panel 21 CFR Section Regulation Name---------------- No. -------------------------------------- ------------------ Product Code_Device Name------------------------------------------------------------------------ RA 892.1000 Magnetic Resonance Diagnostic Device ................ MOS_COIL, Magnetic Resonance, Specialty ................ LNH_System, Nuclear Magnetic Resonance Imaging ................ LNI_System, Nuclear Magnetic Resonance SpectroscopicDiagnostic Ultrasound: RA 892.1540 Nonfetal Ultrasonic Monitor ................ JAF_Monitor, Ultrasonic, Nonfetal RA 892.1550 Ultrasonic Pulsed Doppler Imaging System ................ IYN_System, Imaging, Pulsed Doppler, Ultrasonic RA 892.1560 Ultrasonic Pulsed Echo Imaging System ................ IYO_System, Imaging, Pulsed Echo, Ultrasonic RA 892.1570 Diagnostic Ultrasonic Transducer ................ ITX_Transducer, Ultrasonic, DiagnosticDiagnostic X- Ray Imaging Devices (except mammographic x- ray systems): RA 892.1600 Angiographic X-Ray System ................ IZI_System, X-Ray, Angiographic RA 892.1650 Image-Intensified Fluoroscopic X-Ray System ................ MQB_Solid State X-Ray Imager (Flat Panel/Digital Imager) ................ JAA_System, X-Ray, Fluoroscopic, Image-Intensified RA 892.1680 Stationary X-Ray System ................ KPR_System, X-Ray, Stationary RA 892.1720 Mobile X-Ray System ................ IZL_System, X-Ray, Mobile RA 892.1740 Tomographic X-Ray System ................ IZF_System, X-Ray, Tomographic RA 892.1750 Computed Tomography X-Ray System ................ JAK_System, X-Ray, Tomography, ComputedECG-Related Devices: CV 870.2340 Electrocardiograph ................ DPS_Electrocardiograph ................ MLC_Monitor, ST Segment CV 870.2350 Electrocardiograph Lead Switching Adaptor ................ DRW_Adaptor, Lead Switching, Electrocardiograph CV 870.2360 Electrocardiograph Electrode ................ DRX_Electrode, Electrocardiograph CV 870.2370 Electrocardiograph Surface Electrode Tester ................ KRC_Tester, Electrode, Surface, Electrocardiographic NE 882.1400 Electroencephalograph ................ GWQ_Electroencephalograph HO 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 ................ LZG_Pump, Infusion, Insulin ................ MEA_Pump, Infusion, PCAOphthalmic Instruments: OP 886.1570 Ophthalmoscope ................ HLI_Ophthalmoscope, AC-Powered ................ HLJ_Ophthalmoscope, Battery-Powered OP 886.1780 Retinoscope ................ HKL_Retinoscope, AC-Powered OP 886.1850 AC-Powered Slit-Lamp Biomicroscope ................ HJO_Biomicroscope, Slit-Lamp, AC- Powered OP 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 OP 886.4670 Phacofragmentation System ................ HQC_Unit, Phacofragmentation SU 878.4580 Surgical Lamp ................ HBI_Illuminator, Fiberoptic, Surgical Field ................ FTF_Illuminator, Nonremote ................ 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 NE 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Relief ................ GZJ_Stimulator, Nerve, Transcutaneous, For Pain Relief ................ Noninvasive Blood Pressure Measurement Devices: CV 870.1120 Blood Pressure Cuff ................ DXQ_Cuff, Blood-Pressure CV 870.1130 Noninvasive Blood Pressure Measurement System (except nonoscillometric) ................ DXN_System, Measurement, Blood- Pressure, Noninvasive HO 880.6880 Steam Sterilizer (greater than 2 cubic feet) ................ FLE_Sterilizer, SteamClinical Thermometers: HO 880.2910 Clinical Electronic Thermometer (except tympanic or pacifier) ................ FLL_Thermometer, Electronic, Clinical AN 868.5630 Nebulizer ................ CAF_Nebulizer (Direct Patient Interface)Hypodermic Needles and Syringes (except antistick and self- destruct): HO 880.5570 Hypodermic Single Lumen Needle ................ MMK_Container, Sharpes ................ FMI_Needle, Hypodermic, Single Lumen ................ MHC_Port, Intraosseous, Implanted HO 880.5860 Piston Syringe ................ FMF_Syringe, PistonSelected Dental Materials: DE 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 DE 872.3200 Resin Tooth Bonding Agent ................ KLE_Agent, Tooth Bonding, Resin DE 872.3275 Dental Cement ................ EMA_Cement, Dental ................ EMB_Zinc Oxide Eugenol DE 872.3660 Impression Material ................ ELW_Material, Impression DE 872.3690 Tooth Shade Resin Material ................ EBF_Material, Tooth Shade, Resin DE 872.3710 Base Metal Alloy ................ EJH_Metal, BaseLatex Condoms: OB 884.5300 Condom ................ HIS_Condom------------------------------------------------------------------------\1\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.php.
Table 3_Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period\1\------------------------------------------------------------------------ Product Family 21 CFR Section No Device Name Tier------------------------------------------------------------------------Anesthesiology Panel Anesthesia 868.5160 Gas machine for 2 Devices anesthesia or analgesia 868.5270 Breathing system 2 heater 868.5440 Portable oxygen 2 generator 868.5450 Respiratory gas 2 humidifier 868.5630 Nebulizer 2 868.5710 Electrically 2 powered oxygen tent 868.5880 Anesthetic 2 vaporizer Gas Analyser 868.1040 Powered 2 Algesimeter 868.1075 Argon gas 2 analyzer 868.1400 Carbon dioxide 2 gas analyzer 868.1430 Carbon monoxide 2 gas analyzer 868.1500 Enflurane gas 2 analyzer 868.1620 Halothane gas 2 analyzer 868.1640 Helium gas 2 analyzer 868.1670 Neon gas 2 analyzer 868.1690 Nitrogen gas 2 analyzer 868.1700 Nitrous oxide 2 gas analyzer 868.1720 Oxygen gas 2 analyzer 868.1730 Oxygen uptake 2 computer Peripheral 868.2775 Electrical 2 Nerve peripheral Stimulators nerve stimulator Respiratory 868.1750 Pressure 2 Monitoring plethysmograph 868.1760 Volume 2 plethysmograph 868.1780 Inspiratory 2 airway pressure meter 868.1800 Rhinoanemometer 2 868.1840 Diagnostic 2 spirometer 868.1850 Monitoring 2 spirometer 868.1860 Peak-flow meter 2 for spirometry 868.1880 Pulmonary- 2 function data calculator 868.1890 Predictive 2 pulmonary- function value calculator 868.1900 Diagnostic 2 pulmonary- function interpretation calculator 868.2025 Ultrasonic air 2 embolism monitor 868.2375 Breathing 2 frequency monitor (except apnea detectors) 868.2480 Cutaneous carbon 2 dioxide (PcCO2) monitor 868.2500 Cutaneous oxygen 2 monitor (for an infant not under gas anesthesia) 868.2550 Pneumotachomomet 2 er 868.2600 Airway pressure 2 monitor 868.5665 Powered 2 percussor 868.5690 Incentive 2 spirometer Ventilator 868.5905 Noncontinuous 2 ventilator (IPPB) 868.5925 Powered 2 emergency ventilator 868.5935 External 2 negative pressure ventilator 868.5895 Continuous 2 ventilator 868.5955 Intermittent 2 mandatory ventilation attachment 868.6250 Portable air 2 compressorCardiovascular Panel Cardiovascula 870.1425 Programmable 2 r Diagnostic diagnostic computer 870.1450 Densitometer 2 870.2310 Apex cardiograph 2 (vibrocardiogra ph) 870.2320 Ballistocardiogr 2 aph 870.2340 Electrocardiogra 2 ph 870.2350 Electrocardiogra 1 ph lead switching adaptor 870.2360 Electrocardiogra 2 ph electrode 870.2370 Electrocardiogra 2 ph surface electrode tester 870.2400 Vectorcardiograp 1 h 870.2450 Medical cathode- 1 ray tube display 870.2675 Oscillometer 2 870.2840 Apex 2 cardiographic transducer 870.2860 Heart sound 2 transducer Cardiovascula ................. Valve, pressure r Monitoring relief, cardiopulmonary bypass 870.1100 Blood pressure 2 alarm 870.1110 Blood pressure 2 computer 870.1120 Blood pressure 2 cuff 870.1130 Noninvasive 2 blood pressure measurement system 870.1140 Venous blood 2 pressure manometer 870.1220 Electrode 2 recording catheter or electrode recording probe 870.1270 Intracavitary 2 phonocatheter system 870.1875 Stethoscope 2 (electronic) 870.2050 Biopotential 2 amplifier and signal conditioner 870.2060 Transducer 2 signal amplifier and conditioner 870.2100 Cardiovascular 2 blood flow- meter 870.2120 Extravascular 2 blood flow probe 870.2300 Cardiac monitor 2 (including cardiotachomete r and rate alarm) 870.2700 Oximeter 2 870.2710 Ear oximeter 2 870.2750 Impedance 2 phlebograph 870.2770 Impedance 2 plethysmograph 870.2780 Hydraulic, 2 pneumatic, or photoelectric plethysmographs 870.2850 Extravascular 2 blood pressure transducer 870.2870 Catheter tip 2 pressure transducer 870.2880 Ultrasonic 2 transducer 870.2890 Vessel occlusion 2 transducer 870.2900 Patient 2 transducer and electrode cable (including connector) 870.2910 Radiofrequency 2 physiological signal transmitter and receiver 870.2920 Telephone 2 electrocardiogr aph transmitter and receiver 870.4205 Cardiopulmonary 2 bypass bubble detector 870.4220 Cardiopulmonary 2 bypass heart- lung machine console 870.4240 Cardiovascular 2 bypass heat exchanger 870.4250 Cardiopulmonary 2 bypass temperature controller 870.4300 Cardiopulmonary 2 bypass gas control unit 870.4310 Cardiopulmonary 2 bypass coronary pressure gauge 870.4330 Cardiopulmonary 2 bypass on-line blood gas monitor 870.4340 Cardiopulmonary 2 bypass level sensing monitor and/or control 870.4370 Roller-type 2 cardiopulmonary bypass blood pump 870.4380 Cardiopulmonary 2 bypass pump speed control 870.4410 Cardiopulmonary 2 bypass in-line blood gas sensor Cardiovascula 870.5050 Patient care 2 r suction Therapeutic apparatus 870.5900 Thermal 2 regulation system Defibrillator 870.5300 DC-defibrillator 2 (including paddles) 870.5325 Defibrillator 2 tester Echocardiogra 870.2330 Echocardiograph 2 ph Pacemaker 870.1750 External 2 & programmable Accessories pacemaker pulse generator 870.3630 Pacemaker 2 generator function analyzer 870.3640 Indirect 2 pacemaker generator function analyzer 870.3720 Pacemaker 2 electrode function tester Miscellaneous 870.1800 Withdrawal- 2 infusion pump 870.2800 Medical magnetic 2 tape recorder None Batteries, rechargeable, class II devicesDental Panel Dental 872.1720 Pulp tester 2 Equipment 872.1740 Caries detection 2 device 872.4120 Bone cutting 2 instrument and accessories 872.4465 Gas-powered jet 2 injector 872.4475 Spring-powered 2 jet injector 872.4600 Intraoral 2 ligature and wire lock 872.4840 Rotary scaler 2 872.4850 Ultrasonic 2 scaler 872.4920 Dental 2 electrosurgical unit and accessories 872.6070 Ultraviolet 2 activator for polymerization 872.6350 Ultraviolet 2 detector Dental 872.3050 Amalgam alloy 2 Material 872.3060 Gold-based 2 alloys and precious metal alloys for clinical use 872.3200 Resin tooth 2 bonding agent 872.3250 Calcium 2 hydroxide cavity liner 872.3260 Cavity varnish 2 872.3275 Dental cement 2 (other than zinc oxide- eugenol) 872.3300 Hydrophilic 2 resin coating for dentures 872.3310 Coating material 2 for resin fillings 872.3590 Preformed 2 plastic denture tooth 872.3660 Impression 2 material 872.3690 Tooth shade 2 resin material 872.3710 Base metal alloy 2 872.3750 Bracket adhesive 2 resin and tooth conditioner 872.3760 Denture 2 relining, repairing, or rebasing resin 872.3765 Pit and fissure 2 sealant and conditioner 872.3770 Temporary crown 2 and bridge resin 872.3820 Root canal 2 filling resin (other than chloroform use) 872.3920 Porcelain tooth 2 Dental X-ray 872.1800 Extraoral source 2 x-ray system 872.1810 Intraoral source 2 x-ray system Dental 872.4880 Intraosseous 2 Implants fixation screw or wire 872.3890 Endodontic 2 stabilizing splint Orthodontic 872.5470 Orthodontic 2 plastic bracketEar/Nose/Throat Panel Diagnostic 874.1050 Audiometer 2 Equipment 874.1090 Auditory 2 impedance tester 874.1120 Electronic noise 2 generator for audiometric testing 874.1325 Electroglottogra 2 ph 874.1820 Surgical nerve 2 stimulator/ locator Hearing Aids 874.3300 Hearing aid (for 2 bone- conduction) 874.3310 Hearing aid 2 calibrator and analysis system 874.3320 Group hearing 2 aid or group auditory trainer 874.3330 Master hearing 2 aid Surgical 874.4250 Ear, nose, and 1 Equipment throat electric or pneumatic surgical drill 874.4490 Argon laser for 2 otology, rhinology, and laryngology 874.4500 Ear, nose, and 2 throat microsurgical carbon dioxide laserGastroenterology/ Urology Panel Endoscope 876.1500 Endoscope and 2 (including accessories angioscopes, laparscopes, ophthalmic endoscopes) 876.4300 Endoscopic 2 electrosurgical unit and accessories Gastroenterol 876.1725 Gastrointestinal 1 ogy motility monitoring system Hemodialysis 876.5600 Sorbent 2 regenerated dialysate delivery system for hemodialysis 876.5630 Peritoneal 2 dialysis system and accessories 876.5665 Water 2 purification system for hemodialysis 876.5820 Hemodialysis 2 system and accessories 876.5830 Hemodialyzer 2 with disposable insert (kiil- type) Lithotriptor 876.4500 Mechanical 2 lithotriptor Urology 876.1620 Urodynamics 2 Equipment measurement system 876.5320 Nonimplanted 2 electrical continence device 876.5880 Isolated kidney 2 perfusion and transport system and accessoriesGeneral Hospital Panel Infusion 880.2420 Electronic 2 Pumps and monitor for Systems gravity flow infusion systems 880.2460 Electrically 2 powered spinal fluid pressure monitor 880.5430 Nonelectrically 2 powered fluid injector 880.5725 Infusion pump 2 Neonatal 880.5400 Neonatal 2 Incubators incubator 880.5410 Neonatal 2 transport incubator 880.5700 Neonatal 2 phototherapy unit Piston 880.5570 Hypodermic 1 Syringes single lumen needle 880.5860 Piston syringe 1 (except antistick) 880.6920 Syringe needle 2 introducer Miscellaneous 880.2910 Clinical 2 electronic thermometer 880.2920 Clinical mercury 2 thermometer 880.5100 AC-powered 1 adjustable hospital bed 880.5500 AC-powered 2 patient lift 880.6880 Steam sterilizer 2 (greater than 2 cubic feet)Neurology Panel 882.1020 Rigidity 2 analyzer 882.1610 Alpha monitor 2 Neuro- 882.1320 Cutaneous 2 Diagnostic electrode 882.1340 Nasopharyngeal 2 electrode 882.1350 Needle electrode 2 882.1400 Electroencephalo 2 graph 882.1460 Nystagmograph 2 882.1480 Neurological 2 endoscope 882.1540 Galvanic skin 2 response measurement device 882.1550 Nerve conduction 2 velocity measurement device 882.1560 Skin potential 2 measurement device 882.1570 Powered direct- 2 contact temperature measurement device 882.1620 Intracranial 2 pressure monitoring device 882.1835 Physiological 2 signal amplifier 882.1845 Physiological 2 signal conditioner 882.1855 Electroencephalo 2 gram (EEG) telemetry system 882.5050 Biofeedback 2 device Echoencephalo 882.1240 Echoencephalogra 2 graphy ph RPG 882.4400 Radiofrequency 2 lesion generator Neuro Surgery none Electrode, 2 spinal epidural 882.4305 Powered compound 2 cranial drills, burrs, trephines, and their accessories 882.4310 Powered simple 2 cranial drills burrs, trephines, and their accessories 882.4360 Electric cranial 2 drill motor 882.4370 Pneumatic 2 cranial drill motor 882.4560 Stereotaxic 2 instrument 882.4725 Radiofrequency 2 lesion probe 882.4845 Powered rongeur 2 882.5500 Lesion 2 temperature monitor Stimulators 882.1870 Evoked response 2 electrical stimulator 882.1880 Evoked response 2 mechanical stimulator 882.1890 Evoked response 2 photic stimulator 882.1900 Evoked response 2 auditory stimulator 882.1950 Tremor 2 transducer 882.5890 Transcutaneous 2 electrical nerve stimulator for pain reliefObstetrics/ Gynecology Panel Fetal 884.1660 Transcervical 2 Monitoring endoscope (amnioscope) and accessories 884.1690 Hysteroscope and 2 accessories (for performance standards) 884.2225 Obstetric- 2 gynecologic ultrasonic imager 884.2600 Fetal cardiac 2 monitor 884.2640 Fetal 2 phonocardiograp hic monitor and accessories 884.2660 Fetal ultrasonic 2 monitor and accessories 884.2675 Fetal scalp 1 circular (spiral) electrode and applicator 884.2700 Intrauterine 2 pressure monitor and accessories 884.2720 External uterine 2 contraction monitor and accessories 884.2740 Perinatal 2 monitoring system and accessories 884.2960 Obstetric 2 ultrasonic transducer and accessories Gynecological 884.1720 Gynecologic 2 Surgery laparoscope and Equipment accessories 884.4160 Unipolar 2 endoscopic coagulator- cutter and accessories 884.4550 Gynecologic 2 surgical laser 884.4120 Gynecologic 2 electrocautery and accessories 884.5300 Condom 2 Ophthalmic 886.3320 Eye sphere 2 Implants implant Contact Lens 886.1385 Polymethylmethac 2 rylate (PMMA) diagnostic contact lens 886.5916 Rigid gas 2 permeable contact lens (daily wear only) Diagnostic 886.1120 Opthalmic camera 1 Equipment 886.1220 Corneal 1 electrode 886.1250 Euthyscope (AC- 1 powered) 886.1360 Visual field 1 laser instrument 886.1510 Eye movement 1 monitor 886.1570 Ophthalmoscope 1 886.1630 AC-powered 1 photostimulator 886.1640 Ophthalmic 1 preamplifier 886.1670 Ophthalmic 2 isotope uptake probe 886.1780 Retinoscope (AC- 1 powered device) 886.1850 AC-powered slit 1 lamp biomicroscope 886.1930 Tonometer and 2 accessories 886.1945 Transilluminator 1 (AC-powered device) 886.3130 Ophthalmic 2 conformer (Diagnostic/ 886.4670 Phacofragmentati 2 Surgery on system Equipment) Ophthalmic 886.3340 Extraocular 2 Implants orbital implant 886.3800 Scleral shell 2 Surgical 880.5725 Infusion pump 2 Equipment (performance standards) 886.3100 Ophthalmic 2 tantalum clip 886.3300 Absorbable 2 implant (scleral buckling method) 886.4100 Radiofrequency 2 electrosurgical cautery apparatus 886.4115 Thermal cautery 2 unit 886.4150 Vitreous 2 aspiration and cutting instrument 886.4170 Cryophthalmic 2 unit 886.4250 Ophthalmic 1 electrolysis unit (AC- powered device) 886.4335 Operating 1 headlamp (AC- powered device) 886.4390 Ophthalmic laser 2 886.4392 Nd:YAG laser for 2 posterior capsulotomy 886.4400 Electronic metal 1 locator 886.4440 AC-powered 1 magnet 886.4610 Ocular pressure 2 applicator 886.4690 Ophthalmic 2 photocoagulator 886.4790 Ophthalmic 2 sponge 886.5100 Ophthalmic beta 2 radiation source none Ophthalmoscopes, 1 replacement batteries, hand- heldOrthopedic Panel Implants 888.3010 Bone fixation 2 cerclage 888.3020 Intramedullary 2 fixation rod 888.3030 Single/multiple 2 component metallic bone fixation appliances and accessories 888.3040 Smooth or 2 threaded metallic bone fixation fastener 888.3050 Spinal 2 interlaminal fixation orthosis 888.3060 Spinal 2 intervertebral body fixation orthosis Surgical 888.1240 AC-powered 2 Equipment dynamometer 888.4580 Sonic surgical 2 instrument and accessories/ attachments none Accessories, 2 fixation, spinal interlaminal none Accessories, 2 fixation, spinal intervertebral body none Monitor, 1 pressure, intracompartmen tal none Orthosis, 2 fixation, spinal intervertebral fusion none Orthosis, spinal pedicle fixation none System, cement 1 removal extractionPhysical Medicine Panel Diagnostic 890.1225 Chronaximeter 2 Equipment or (Therapy) Therapeutic Equipment 890.1375 Diagnostic 2 electromyograph 890.1385 Diagnostic 2 electromyograph needle electrode 890.1450 Powered reflex 2 hammer 890.1850 Diagnostic 2 muscle stimulator or (Therapy) 890.5850 Powered muscle 2 stimulator Therapeutic 890.5100 Immersion 2 Equipment hydrobath 890.5110 Paraffin bath 2 890.5500 Infrared lamp 2 890.5720 Water 2 circulating hot or cold pack 890.5740 Powered heating 2 padRadiology Panel MRI 892.1000 Magnetic 2 resonance diagnostic device Ultrasound 884.2660 Fetal ultrasonic 2 Diagnostic monitor and accessories 892.1540 Nonfetal ultrasonic monitor 892.1560 Ultrasonic 2 pulsed echo imaging system 892.1570 Diagnostic 2 ultrasonic transducer 892.1550 Ultrasonic pulsed doppler imaging system Angiographic 892.1600 Angiographic x- 2 ray system Diagnostic X- 892.1610 Diagnostic x-ray 2 Ray beam-limiting device 892.1620 Cine or spot 2 fluorographic x- ray camera 892.1630 Electrostatic x- 2 ray imaging system 892.1650 Image- 2 intensified fluoroscopic x- ray system 892.1670 Spot film device 2 892.1680 Stationary x-ray 2 system 892.1710 Mammographic x- 2 ray system 892.1720 Mobile x-ray 2 system 892.1740 Tomographic x- 1 ray system 892.1820 Pneumoencephalog 2 raphic chair 892.1850 Radiographic 1 film cassette 892.1860 Radiographic 1 film/cassette changer 892.1870 Radiographic 2 film/cassette changer programmer 892.1900 Automatic 2 radiographic film processor 892.1980 Radiologic table 1 CT Scanner 892.1750 Computed 2 tomography x- ray system Radiation 892.5050 Medical charged- 2 Therapy particle radiation therapy system 892.5300 Medical neutron 2 radiation therapy system 892.5700 Remote 2 controlled radionuclide applicator system 892.5710 Radiation 2 therapy beam- shaping block 892.5730 Radionuclide 2 brachytherapy source 892.5750 Radionuclide 2 radiation therapy system 892.5770 Powered 2 radiation therapy patient support assembly 892.5840 Radiation 2 therapy simulation system 892.5930 Therapeutic x- 1 ray tube housing assembly Nuclear 892.1170 Bone 2 Medicine densitometer 892.1200 Emission 2 computed tomography system 892.1310 Nuclear 1 tomography system 892.1390 Radionuclide 2 rebreathing systemGeneral/Plastic Surgery Panel Surgical 878.4630 Ultraviolet lamp 2 Lamps for dermatologic disorders 890.5500 Infrared lamp 2 878.4580 Surgical lamp 2 Electrosurgic 878.4810 Laser surgical 2 al Cutting instrument for Equipment use in general and plastic surgery and in dermatology 878.4400 Electrosurgical 2 cutting and coagulation device and accessories Miscellaneous 878.4780 Powered suction 2 pump------------------------------------------------------------------------\1\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.php.
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[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]
Appendixes C–F to Subpart B of Part 26 [Reserved]
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Subpart C—“Framework” Provisions
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§ 26.60 Definitions.
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(a) The following terms and definitions shall apply to this subpart only:
(1) Designating Authority means a body with power to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies as specified under this part.
(2) Designation means the identification by a designating authority of a conformity assessment body to perform conformity assessment procedures under this part.
(3) Regulatory Authority means a government agency or entity that exercises a legal right to control the use or sale of products within a party's jurisdiction and may take enforcement action to ensure that products marketed within its jurisdiction comply with legal requirements.
(b) Other terms concerning conformity assessment used in this part shall have the meaning given elsewhere in this part or in the definitions contained in “Guide 2: Standardization and Related Activities—General Vocabulary of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC)” (ISO/IEC Guide 2) (1996 edition), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the International Organization for Standardization, 1, rue de Varembé, Case postale 56, CH–1211 Genève 20, Switzerland, or on the Internet at http://www.iso.ch or may be examined at the Food and Drug Administration's Medical Library, 5600 Fishers Lane, rm. 11B–40, Rockville, MD 20857, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. In the event of an inconsistency between the ISO/IEC Guide 2 and definitions in this part, the definitions in this part shall prevail.
§ 26.61 Purpose of this part.
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This part specifies the conditions by which each party will accept or recognize results of conformity assessment procedures, produced by the other party's conformity assessment bodies (CAB's) or authorities, in assessing conformity to the importing party's requirements, as specified on a sector-specific basis in subparts A and B of this part, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the parties with regard to conformity assessment for all products covered under this part. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the party alleging its market access has been denied may, within 90 days of such consultation, invoke its right to terminate the “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived, in accordance with §26.80.
§ 26.62 General obligations.
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(a) The United States shall, as specified in subparts A and B of this part, accept or recognize results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the United States, produced by the other party's conformity assessment bodies (CAB's) and/or authorities.
(b) The European Community (EC) and its Member States shall, as specified in subparts A and B of this part, accept or recognize results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the EC and its Member States, produced by the other party's CAB's and/or authorities.
(c) Where sectoral transition arrangements have been specified in subparts A and B of this part, the obligations in paragraphs (a) and (b) of this section will apply following the successful completion of those sectoral transition arrangements, with the understanding that the conformity assessment procedures utilized assure conformity to the satisfaction of the receiving party, with applicable legislative, regulatory, and administrative provisions of that party, equivalent to the assurance offered by the receiving party's own procedures.
§ 26.63 General coverage of this part.
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(a) This part applies to conformity assessment procedures for products and/or processes and to other related cooperative activities as described in this part.
(b) Subparts A and B of this part may include:
(1) A description of the relevant legislative, regulatory, and administrative provisions pertaining to the conformity assessment procedures and technical regulations;
(2) A statement on the product scope and coverage;
(3) A list of designating authorities;
(4) A list of agreed conformity assessment bodies (CAB's) or authorities or a source from which to obtain a list of such bodies or authorities and a statement of the scope of the conformity assessment procedures for which each has been agreed;
(5) The procedures and criteria for designating the CAB's;
(6) A description of the mutual recognition obligations;
(7) A sectoral transition arrangement;
(8) The identity of a sectoral contact point in each party's territory; and
(9) A statement regarding the establishment of a Joint Sectoral Committee.
(c) This part shall not be construed to entail mutual acceptance of standards or technical regulations of the parties and, unless otherwise specified in subpart A or B of this part, shall not entail the mutual recognition of the equivalence of standards or technical regulations.
§ 26.64 Transitional arrangements.
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The parties agree to implement the transitional commitments on confidence building as specified in subparts A and B of this part.
(a) The parties agree that each sectoral transitional arrangement shall specify a time period for completion.
(b) The parties may amend any transitional arrangement by mutual agreement.
(c) Passage from the transitional phase to the operational phase shall proceed as specified in subparts A and B of this part, unless either party documents that the conditions provided in such subpart for a successful transition are not met.
§ 26.65 Designating authorities.
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The parties shall ensure that the designating authorities specified in subpart B of this part have the power and competence in their respective territories to carry out decisions under this part to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies (CAB's).
§ 26.66 Designation and listing procedures.
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The following procedures shall apply with regard to the designation of conformity assessment bodies (CAB's) and the inclusion of such bodies in the list of CAB's in subpart B of this part:
(a) The designating authority identified in subpart B of this part shall designate CAB's in accordance with the procedures and criteria set forth in subpart B of this part;
(b) A party proposing to add a CAB to the list of such bodies in subpart B of this part shall forward its proposal of one or more designated CAB's in writing to the other party with a view to a decision by the Joint Committee;
(c) Within 60 days following receipt of the proposal, the other party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in subpart B of this part of the proposed CAB or CAB's shall take effect; and
(d) In the event that the other party contests on the basis of documented evidence the technical competence or compliance of a proposed CAB, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such CAB shall not be included on the list of CAB's in subpart B of this part. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the proposal to list the CAB in subpart B may be resubmitted to the other party.
§ 26.67 Suspension of listed conformity assessment bodies.
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The following procedures shall apply with regard to the suspension of a conformity assessment body (CAB) listed in subpart B of this part.
(a) A party shall notify the other party of its contestation of the technical competence or compliance of a CAB listed in subpart B of this part and the contesting party's intent to suspend such CAB. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other party;
(b) The CAB shall be given prompt notice by the other party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation;
(c) Any such contestation shall be discussed between the parties in the Joint Sectoral Committee described in subpart B of this part. If there is no Joint Sectoral Committee, the contesting party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
(d) Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the party in whose territory the body in question is located, but may be carried out jointly by the parties in justified cases;
(e) If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the CAB shall be suspended upon the request of the contesting party;
(f) Upon the suspension of a CAB listed in subpart B of this part, a party is no longer obligated to accept or recognize the results of conformity assessment procedures performed by that CAB subsequent to suspension. A party shall continue to accept the results of conformity assessment procedures performed by that CAB prior to suspension, unless a regulatory authority of the party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of subpart B of this part; and
(g) The suspension shall remain in effect until agreement has been reached by the parties upon the future status of that body.
§ 26.68 Withdrawal of listed conformity assessment bodies.
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The following procedures shall apply with regard to the withdrawal from subpart B of this part of a conformity assessment body (CAB):
(a) A party proposing to withdraw a CAB listed in subpart B of this part shall forward its proposal in writing to the other party;
(b) Such CAB shall be promptly notified by the other party and shall be provided a period of at least 30 days from receipt to provide information in order to refute or to correct the deficiencies which form the basis of the proposed withdrawal;
(c) Within 60 days following receipt of the proposal, the other party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the withdrawal from the list in subpart B of this part of the CAB shall take effect;
(d) In the event the other party opposes the proposal to withdraw by supporting the technical competence and compliance of the CAB, the CAB shall not at that time be withdrawn from the list of CAB's in subpart B of this part. In this instance, the Joint Sectoral Committee or the Joint Committee may decide to carry out a joint verification of the body concerned. After the completion of such verification, the proposal for withdrawal of the CAB may be resubmitted to the other party; and
(e) Subsequent to the withdrawal of a CAB listed in subpart B of this part, a party shall continue to accept the results of conformity assessment procedures performed by that CAB prior to withdrawal, unless a regulatory authority of the party decides otherwise based on health, safety, and environmental considerations or failure to satisfy other requirements within the scope of subpart B of this part.
§ 26.69 Monitoring of conformity assessment bodies.
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The following shall apply with regard to the monitoring of conformity assessment bodies (CAB's) listed in subpart B of this part:
(a) Designating authorities shall assure that their CAB's listed in subpart B of this part are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in subpart B of this part. In this regard, designating authorities shall maintain, or cause to maintain, ongoing surveillance over their CAB's by means of regular audit or assessment;
(b) The parties undertake to compare methods used to verify that the CAB's listed in subpart B of this part comply with the relevant requirements of subpart B of this part. Existing systems for the evaluation of CAB's may be used as part of such comparison procedures;
(c) Designating authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of CAB's listed in subpart B of this part; and
(d) Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other party to ensure that all technical requirements are identified and are satisfactorily addressed.
§ 26.70 Conformity assessment bodies.
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Each party recognizes that the conformity assessment bodies (CAB's) listed in subpart B of this part fulfill the conditions of eligibility to assess conformity in relation to its requirements as specified in subpart B of this part. The parties shall specify the scope of the conformity assessment procedures for which such bodies are listed.
§ 26.71 Exchange of information.
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(a) The parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in subparts A and B of this part.
(b) Each party shall notify the other party of legislative, regulatory, and administrative changes related to the subject matter of this part at least 60 days before their entry into force. Where considerations of safety, health or environmental protection require more urgent action, a party shall notify the other party as soon as practicable.
(c) Each party shall promptly notify the other party of any changes to its designating authorities and/or conformity assessment bodies (CAB's).
(d) The parties shall exchange information concerning the procedures used to ensure that the listed CAB's under their responsibility comply with the legislative, regulatory, and administrative provisions outlined in subpart B of this part.
(e) Regulatory authorities identified in subparts A and B of this part shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed.
§ 26.72 Sectoral contact points.
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Each party shall appoint and confirm in writing contact points to be responsible for activities under subparts A and B of this part.
§ 26.73 Joint Committee.
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(a) A Joint Committee consisting of representatives of the United States and the European Community (EC) will be established. The Joint Committee shall be responsible for the effective functioning of the “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived.
(b) The Joint Committee may establish Joint Sectoral Committees comprised of appropriate regulatory authorities and others deemed necessary.
(c) The United States and the EC shall each have one vote in the Joint Committee. The Joint Committee shall make its decisions by unanimous consent. The Joint Committee shall determine its own rules and procedures.
(d) The Joint Committee may consider any matter relating to the effective functioning of that agreement. In particular it shall be responsible for:
(1) Listing, suspension, withdrawal and verification of conformity assessment bodies (CAB's) in accordance with that agreement;
(2) Amending transitional arrangements in the sectoral annexes to that agreement;
(3) Resolving any questions relating to the application of that agreement not otherwise resolved in the respective Joint Sectoral Committees;
(4) Providing a forum for discussion of issues that may arise concerning the implementation of that agreement;
(5) Considering ways to enhance the operation of that agreement;
(6) Coordinating the negotiation of additional sectoral annexes to that agreement; and
(7) Considering whether to amend that agreement in accordance with §26.80.
(e) When a party introduces new or additional conformity assessment procedures affecting a sectoral annex to that agreement, the parties shall discuss the matter in the Joint Committee with a view to bringing such new or additional procedures within the scope of that agreement and the relevant sectoral annex.
§ 26.74 Preservation of regulatory authority.
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(a) Nothing in this part shall be construed to limit the authority of a party to determine, through its legislative, regulatory, and administrative measures, the level of protection it considers appropriate for safety; for protection of human, animal, or plant life or health; for the environment; for consumers; and otherwise with regard to risks within the scope of the applicable subpart A or B of this part.
(b) Nothing in this part shall be construed to limit the authority of a regulatory authority to take all appropriate and immediate measures whenever it ascertains that a product may:
(1) Compromise the health or safety of persons in its territory;
(2) Not meet the legislative, regulatory, or administrative provisions within the scope of the applicable subpart A or B of this part; or
(3) Otherwise fail to satisfy a requirement within the scope of the applicable subpart A or B of this part. Such measures may include withdrawing the products from the market, prohibiting their placement on the market, restricting their free movement, initiating a product recall, and preventing the recurrence of such problems, including through a prohibition on imports. If the regulatory authority takes such action, it shall inform its counterpart authority and the other party within 15 days of taking such action, providing its reasons.
§ 26.75 Suspension of recognition obligations.
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Either party may suspend its obligations under subpart A or B of this part, in whole or in part, if:
(a) A party suffers a loss of market access for the party's products within the scope of subpart A or B of this part as a result of the failure of the other party to fulfill its obligations under this part;
(b) The adoption of new or additional conformity assessment requirements as referenced in §26.73(e) results in a loss of market access for the party's products within the scope of subpart B of this part because conformity assessment bodies (CAB's) designated by the party in order to meet such requirements have not been recognized by the party implementing the requirements; or
(c) The other party fails to maintain legal and regulatory authorities capable of implementing the provisions of this part.
§ 26.76 Confidentiality.
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(a) Each party agrees to maintain, to the extent required under its laws, the confidentiality of information exchanged under this part.
(b) In particular, neither party shall disclose to the public, nor permit a conformity assessment body (CAB) to disclose to the public, information exchanged under this part that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation.
(c) A party or a CAB may, upon exchanging information with the other party or with a CAB of the other party, designate the portions of the information that it considers to be exempt from disclosure.
(d) Each party shall take all precautions reasonably necessary to protect information exchanged under this part from unauthorized disclosure.
§ 26.77 Fees.
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Each party shall endeavor to ensure that fees imposed for services under this part shall be commensurate with the services provided. Each party shall ensure that, for the sectors and conformity assessment procedures covered under this part, it shall charge no fees with respect to conformity assessment services provided by the other party.
§ 26.78 Agreements with other countries.
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Except where there is written agreement between the parties, obligations contained in mutual recognition agreements concluded by either party with a party not a party to the agreement from which this part is derived (a third party) shall have no force and effect with regard to the other party in terms of acceptance of the results of conformity assessment procedures in the third party.
§ 26.79 Territorial application.
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The agreement from which this part is derived shall apply, on the one hand, to the territories in which the Treaty establishing the European Community (EC) is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.
§ 26.80 Entry into force, amendment, and termination.
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(a) The “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived, including its sectoral annexes on telecommunication equipment, electromagnetic compatibility, electrical safety, recreational craft, pharmaceutical Good Manufacturing Practices (GMP) inspections, and medical devices shall enter into force on the first day of the second month following the date on which the parties have exchanged letters confirming the completion of their respective procedures for the entry into force of that agreement.
(b) That agreement including any sectoral annex may, through the Joint Committee, be amended in writing by the parties to that agreement. Those parties may add a sectoral annex upon the exchange of letters. Such annex shall enter into force 30 days following the date on which those parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the sectoral annex.
(c) Either party to that agreement may terminate that agreement in its entirety or any individual sectoral annex thereof by giving the other party to that agreement 6-months notice in writing. In the case of termination of one or more sectoral annexes, the parties to that agreement will seek to achieve by consensus to amend that agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this section. Failing such consensus, that agreement shall terminate at the end of 6 months from the date of notice.
(d) Following termination of that agreement in its entirety or any individual sectoral annex thereof, a party to that agreement shall continue to accept the results of conformity assessment procedures performed by conformity assessment bodies under that agreement prior to termination, unless a regulatory authority in the party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable sectoral annex.
§ 26.81 Final provisions.
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(a) The sectoral annexes referred to in §26.80(a), as well as any new sectoral annexes added pursuant to §26.80(b), shall form an integral part of the “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived.
(b) For a given product or sector, the provisions contained in subparts A and B of this part shall apply in the first place, and the provisions of subpart C of this part in addition to those provisions. In the case of any inconsistency between the provisions of subpart A or B of this part and subpart C of this part, subpart A or B shall prevail, to the extent of that inconsistency.
(c) The agreement from which this part is derived shall not affect the rights and obligations of the parties under any other international agreement.
(d) In the case of subpart B of this part, the parties shall review the status of such subpart at the end of 3 years from the date described in §26.80(a).
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