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e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter A → Part 26


Title 21: Food and Drugs


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


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.

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

§26.1   Definitions.

(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.

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.

(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.

(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.

A 3-year transition period will start immediately after the effective date described in §26.80(a).

§26.6   Equivalence assessment.

(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.

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.

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.

(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.

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.

(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.

(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.

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.

(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.

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.

(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.

(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.

(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.

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.

(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.

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

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

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

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

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

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:Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, telephone: 240-402-9153, FAX: 301-595-1302.

Human Drugs: Director, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, phone: 301-796-3100, fax: 301-847-8747.

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; 74 FR 13112, Mar. 26, 2009; 80 FR 18090, Apr. 3, 2015]

Subpart B—Specific Sector Provisions for Medical Devices

§26.31   Purpose.

(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.

(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.

(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.

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.

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.

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.

(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.

(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.

(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.

(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.

(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.

(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.

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.

Transmission of product evaluation reports will take place according to the importing party's specified procedures.

§26.45   Monitoring continued equivalence.

Monitoring activities will be carried out in accordance with §26.69.

§26.46   Listing of additional CAB's.

(a) During the operational period, additional conformity assessment bodies (CAB's) will be considered for equivalence using the procedures and criteria described in §§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.

(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.

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

§26.49   Regulatory cooperation.

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

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

§26.50   Alert system and exchange of postmarket vigilance reports.

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

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

Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.

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

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 United States, Included in Scope of Product Coverage at Beginning of Transition Period1

21 CFR Section No.Regulation Name
   Product Code—Device Name
Anesthesiology Panel (21 CFR part 868)
868.1910Esophageal Stethoscope
   BZW—Stethoscope, Esophageal
868.5620Breathing Mouthpiece
   BYP—Mouthpiece, Breathing
868.5640Medicinal Nonventilatory Nebulizer (Atomizer)
   CCQ—Nebulizer, Medicinal, Nonventilatory (Atomizer)
868.5675Rebreathing Device
   BYW—Device, Rebreathing
868.5700Nonpowered Oxygen Tent
   FOG—Hood, Oxygen, Infant
   BYL—Tent, Oxygen
868.6810Tracheobronchial Suction Catheter
   BSY—Catheters, Suction, Tracheobronchial
Cardiovascular Panel
(None)
Dental Panel (21 CFR part 872)
872.3400Karaya and Sodium Borate With or Without Acacia Denture Adhesive
   KOM—Adhesive, Denture, Acacia and Karaya With Sodium Borate
872.3700Dental Mercury (U.S.P.)
   ELY—Mercury
872.4200Dental 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
872.6640Dental Operative Unit and Accessories
   EIA—Unit, Operative Dental
Ear, Nose, and Throat Panel (21 CFR Part 874)
874.1070Short Increment Sensitivity Index (SISI) Adapter
   ETR—Adapter, Short Increment Sensitivity Index (SISI)
874.1500Gustometer
   ETM—Gustometer
874.1800Air or Water Caloric Stimulator
   KHH—Stimulator, Caloric-Air
   ETP—Stimulator, Caloric-Water
874.1925Toynbee Diagnostic Tube
   ETK—Tube, Toynbee Diagnostic
874.3300Hearing Aid
   LRB—Face Plate Hearing-Aid
   ESD—Hearing-aid, Air-Conduction
874.4100Epistaxis Balloon
   EMX—Balloon, Epistaxis
874.5300ENT Examination and Treatment Unit
   ETF—Unit, Examining/Treatment, ENT
874.5550Powered Nasal Irrigator
   KMA—Irrigator, Powered Nasal
874.5840Antistammering Device
   KTH—Device, Anti-Stammering
Gastroenterology—Urology Panel (21 CFR Part 876)
876.5160Urological Clamp for Males
   FHA—Clamp, Penile
876.5210Enema Kit
   FCE—Kit, Enema, (for Cleaning Purpose)
876.5250Urine Collector and Accessories
   FAQ—Bag, Urine Collection, Leg, for External Use
General Hospital Panel (21 CFR Part 880)
880.5270Neonatal Eye Pad
   FOK—Pad, Neonatal Eye
880.5420Pressure Infusor for an I.V. Bag
   KZD—Infusor, Pressure, for I.V. Bags
880.5680Pediatric Position Holder
   FRP—Holder, Infant Position
880.6250Patient 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
880.6375Patient Lubricant
   KMJ—Lubricant, Patient
880.6760Protective Restraint
   BRT—Restraint, Patient, Conductive
   FMQ—Restraint, Protective
Neurology Panel (21 CFR Part 882)
882.1030Ataxiagraph
   GWW—Ataxiagraph
882.1420Electroencephalogram (EEG) Signal Spectrum Analyzer
   GWS—Analyzer, Spectrum, Electroencephalogram Signal
882.4060Ventricular Cannula
   HCD—Cannula, Ventricular
882.4545Shunt System Implantation Instrument
   GYK—Instrument, Shunt System Implantation
882.4650Neurosurgical Suture Needle
   HAS—Needle, Neurosurgical Suture
882.4750Skull Punch
   GXJ—Punch, Skull
Obstetrics and Gynecology Panel
(None)
Ophthalmology Panel (21 CFR Part 886)
886.1780Retinoscope
   HKM—Retinoscope, Battery-Powered
886.1940Tonometer Sterilizer
   HKZ—Sterilizer, Tonometer
886.4070Powered 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
886.4370Keratome
   HNO—Keratome, AC-Powered
   HMY—Keratome, Battery-Powered
886.5850Sunglasses (Nonprescription)
   HQY—Sunglasses (Nonprescription Including Photosensitive)
Orthopedic Panel (21 CFR Part 888)
888.1500Goniometer
   KQX—Goniometer, AC-Powered
888.4150Calipers for Clinical Use
   KTZ—Caliper
Physical Medicine Panel (21 CFR Part 890)
890.3850Mechanical Wheelchair
   LBE—Stroller, Adaptive
   IOR—Wheelchair, Mechanical
890.5180Manual Patient Rotation Bed
   INY—Bed, Patient Rotation, Manual
890.5710Hot or Cold Disposable Pack
   IMD—Pack, Hot or Cold, Disposable
Radiology Panel (21 CFR Part 892)
892.1100Scintillation (Gamma) Camera
   IYX—Camera, Scintillation (Gamma)
892.1110Positron Camera
   IZC—Camera, Positron
892.1300Nuclear Rectilinear Scanner
   IYW—Scanner, Rectilinear, Nuclear
892.1320Nuclear Uptake Probe
   IZD—Probe, Uptake, Nuclear
892.1330Nuclear Whole Body Scanner
   JAM—Scanner, Whole Body, Nuclear
892.1410Nuclear Electrocardiograph Synchronizer
   IVY—Synchronizer, Electrocardiograph, Nuclear
892.1890Radiographic Film Illuminator
   IXC—Illuminator, Radiographic-Film
   JAG—Illuminator, Radiographic-Film, Explosion-Proof
892.1910Radiographic Grid
   IXJ—Grid, Radiographic
892.1960Radiographic Intensifying Screen
   EAM—Screen, Intensifying, Radiographic
892.1970Radiographic ECG/Respirator Synchronizer
   IXO—Synchronizer, ECG/Respirator, Radiographic
892.5650Manual Radionuclide Applicator System
   IWG—System, Applicator, Radionuclide, Manual
General and Plastic Surgery Panel (21 CFR Part 878)
878.4200Introduction/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
878.4320Removable Skin Clip
   FZQ—Clip, Removable (Skin)
878.4460Surgeon's Gloves
   KGO—Surgeon's Gloves
878.4680Nonpowered, Single Patient, Portable Suction Apparatus
   GCY—Apparatus, Suction, Single Patient Use, Portable, Nonpowered
878.4760Removable Skin Staple
   GDT—Staple, Removable (Skin)
878.4820AC-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
878.4960Air 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
880.5090Liquid Bandage
   KMF—Bandage, Liquid

1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.

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

Panel21 CFR Section No.Regulation Name
      Product Code—Device Name
RA892.1000Magnetic Resonance Diagnostic Device
      MOS—COIL, Magnetic Resonance, Specialty
      LNH—System, Nuclear Magnetic Resonance Imaging
      LNI—System, Nuclear Magnetic Resonance Spectroscopic
Diagnostic Ultrasound:
RA892.1540Nonfetal Ultrasonic Monitor
      JAF—Monitor, Ultrasonic, Nonfetal
RA892.1550Ultrasonic Pulsed Doppler Imaging System
      IYN—System, Imaging, Pulsed Doppler, Ultrasonic
RA892.1560Ultrasonic Pulsed Echo Imaging System
      IYO—System, Imaging, Pulsed Echo, Ultrasonic
RA892.1570Diagnostic Ultrasonic Transducer
      ITX—Transducer, Ultrasonic, Diagnostic
Diagnostic X-Ray Imaging Devices (except mammographic x-ray systems):
RA892.1600Angiographic X-Ray System
      IZI—System, X-Ray, Angiographic
RA892.1650Image-Intensified Fluoroscopic X-Ray System
      MQB—Solid State X-Ray Imager (Flat Panel/Digital Imager)
      JAA—System, X-Ray, Fluoroscopic, Image-Intensified
RA892.1680Stationary X-Ray System
      KPR—System, X-Ray, Stationary
RA892.1720Mobile X-Ray System
      IZL—System, X-Ray, Mobile
RA892.1740Tomographic X-Ray System
      IZF—System, X-Ray, Tomographic
RA892.1750Computed Tomography X-Ray System
      JAK—System, X-Ray, Tomography, Computed
ECG-Related Devices:
CV870.2340Electrocardiograph
      DPS—Electrocardiograph
      MLC—Monitor, ST Segment
CV870.2350Electrocardiograph Lead Switching Adaptor
      DRW—Adaptor, Lead Switching, Electrocardiograph
CV870.2360Electrocardiograph Electrode
      DRX—Electrode, Electrocardiograph
CV870.2370Electrocardiograph Surface Electrode Tester
      KRC—Tester, Electrode, Surface, Electrocardiographic
NE882.1400Electroencephalograph
      GWQ—Electroencephalograph
HO880.5725Infusion 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, PCA
Ophthalmic Instruments:
OP886.1570Ophthalmoscope
   HLI—Ophthalmoscope, AC-Powered
      HLJ—Ophthalmoscope, Battery-Powered
OP886.1780Retinoscope
      HKL—Retinoscope, AC-Powered
OP886.1850AC-Powered Slit-Lamp Biomicroscope
      HJO—Biomicroscope, Slit-Lamp, AC-Powered
OP886.4150Vitreous 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
OP886.4670Phacofragmentation System
      HQC—Unit, Phacofragmentation
SU878.4580Surgical 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
NE882.5890Transcutaneous Electrical Nerve Stimulator for Pain Relief
      GZJ—Stimulator, Nerve, Transcutaneous, For Pain Relief
      Noninvasive Blood Pressure Measurement Devices:
CV870.1120Blood Pressure Cuff
      DXQ—Cuff, Blood-Pressure
CV870.1130Noninvasive Blood Pressure Measurement System (except nonoscillometric)
      DXN—System, Measurement, Blood-Pressure, Noninvasive
HO880.6880Steam Sterilizer (greater than 2 cubic feet)
      FLE—Sterilizer, Steam
Clinical Thermometers:
HO880.2910Clinical Electronic Thermometer (except tympanic or pacifier)
      FLL—Thermometer, Electronic, Clinical
AN868.5630Nebulizer
      CAF—Nebulizer (Direct Patient Interface)
Hypodermic Needles and Syringes (except antistick and self-destruct):
HO880.5570Hypodermic Single Lumen Needle
      MMK—Container, Sharpes
      FMI—Needle, Hypodermic, Single Lumen
      MHC—Port, Intraosseous, Implanted
HO880.5860Piston Syringe
      FMF—Syringe, Piston
Selected Dental Materials:
DE872.3060Gold-Based Alloys and Precious Metal Alloys for Clinical Use
      EJT—Alloy, Gold Based, For Clinical Use
      EJS—Alloy, Precious Metal, For Clinical Use
DE872.3200Resin Tooth Bonding Agent
      KLE—Agent, Tooth Bonding, Resin
DE872.3275Dental Cement
      EMA—Cement, Dental
      EMB—Zinc Oxide Eugenol
DE872.3660Impression Material
      ELW—Material, Impression
DE872.3690Tooth Shade Resin Material
      EBF—Material, Tooth Shade, Resin
DE872.3710Base Metal Alloy
      EJH—Metal, Base
Latex Condoms:
OB884.5300Condom
      HIS—Condom

1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.

Table 3—Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period1

Product Family21 CFR Section NoDevice NameTier
Anesthesiology Panel
Anesthesia Devices868.5160Gas machine for anesthesia or analgesia2
   868.5270Breathing system heater2
   868.5440Portable oxygen generator2
   868.5450Respiratory gas humidifier2
   868.5630Nebulizer2
   868.5710Electrically powered oxygen tent2
   868.5880Anesthetic vaporizer2
Gas Analyser868.1040Powered Algesimeter2
   868.1075Argon gas analyzer2
   868.1400Carbon dioxide gas analyzer2
   868.1430Carbon monoxide gas analyzer2
   868.1500Enflurane gas analyzer2
   868.1620Halothane gas analyzer2
   868.1640Helium gas analyzer2
   868.1670Neon gas analyzer2
   868.1690Nitrogen gas analyzer2
   868.1700Nitrous oxide gas analyzer2
   868.1720Oxygen gas analyzer2
   868.1730Oxygen uptake computer2
Peripheral Nerve Stimulators868.2775Electrical peripheral nerve stimulator2
Respiratory Monitoring868.1750Pressure plethysmograph2
   868.1760Volume plethysmograph2
   868.1780Inspiratory airway pressure meter2
   868.1800Rhinoanemometer2
   868.1840Diagnostic spirometer2
   868.1850Monitoring spirometer2
   868.1860Peak-flow meter for spirometry2
   868.1880Pulmonary-function data calculator2
   868.1890Predictive pulmonary-function value calculator2
   868.1900Diagnostic pulmonary-function interpretation calculator2
   868.2025Ultrasonic air embolism monitor2
   868.2375Breathing frequency monitor (except apnea detectors)2
   868.2480Cutaneous carbon dioxide (PcCO2) monitor2
   868.2500Cutaneous oxygen monitor (for an infant not under gas anesthesia)2
   868.2550Pneumotachomometer2
   868.2600Airway pressure monitor2
   868.5665Powered percussor2
   868.5690Incentive spirometer2
Ventilator868.5905Noncontinuous ventilator (IPPB)2
   868.5925Powered emergency ventilator2
   868.5935External negative pressure ventilator2
   868.5895Continuous ventilator2
   868.5955Intermittent mandatory ventilation attachment2
   868.6250Portable air compressor2
Cardiovascular Panel
Cardiovascular Diagnostic870.1425Programmable diagnostic computer2
   870.1450Densitometer2
   870.2310Apex cardiograph (vibrocardiograph)2
   870.2320Ballistocardiograph2
   870.2340Electrocardiograph2
   870.2350Electrocardiograph lead switching adaptor1
   870.2360Electrocardiograph electrode2
   870.2370Electrocardiograph surface electrode tester2
   870.2400Vectorcardiograph1
   870.2450Medical cathode-ray tube display1
   870.2675Oscillometer2
   870.2840Apex cardiographic transducer2
   870.2860Heart sound transducer2
Cardiovascular Monitoring   Valve, pressure relief, cardiopulmonary bypass
   870.1100Blood pressure alarm2
   870.1110Blood pressure computer2
   870.1120Blood pressure cuff2
   870.1130Noninvasive blood pressure measurement system2
   870.1140Venous blood pressure manometer2
   870.1220Electrode recording catheter or electrode recording probe2
   870.1270Intracavitary phonocatheter system2
   870.1875Stethoscope (electronic)2
   870.2050Biopotential amplifier and signal conditioner2
   870.2060Transducer signal amplifier and conditioner2
   870.2100Cardiovascular blood flow-meter2
   870.2120Extravascular blood flow probe2
   870.2300Cardiac monitor (including cardiotachometer and rate alarm)2
   870.2700Oximeter2
   870.2710Ear oximeter2
   870.2750Impedance phlebograph2
   870.2770Impedance plethysmograph2
   870.2780Hydraulic, pneumatic, or photoelectric plethysmographs2
   870.2850Extravascular blood pressure transducer2
   870.2870Catheter tip pressure transducer2
   870.2880Ultrasonic transducer2
   870.2890Vessel occlusion transducer2
   870.2900Patient transducer and electrode cable (including connector)2
   870.2910Radiofrequency physiological signal transmitter and receiver2
   870.2920Telephone electrocardiograph transmitter and receiver2
   870.4205Cardiopulmonary bypass bubble detector2
   870.4220Cardiopulmonary bypass heart-lung machine console2
   870.4240Cardiovascular bypass heat exchanger2
   870.4250Cardiopulmonary bypass temperature controller2
   870.4300Cardiopulmonary bypass gas control unit2
   870.4310Cardiopulmonary bypass coronary pressure gauge2
   870.4330Cardiopulmonary bypass on-line blood gas monitor2
   870.4340Cardiopulmonary bypass level sensing monitor and/or control2
   870.4370Roller-type cardiopulmonary bypass blood pump2
   870.4380Cardiopulmonary bypass pump speed control2
   870.4410Cardiopulmonary bypass in-line blood gas sensor2
Cardiovascular Therapeutic870.5050Patient care suction apparatus2
   870.5900Thermal regulation system2
Defibrillator870.5300DC-defibrillator (including paddles)2
   870.5325Defibrillator tester2
Echocardiograph870.2330Echocardiograph2
Pacemaker & Accessories870.1750External programmable pacemaker pulse generator2
   870.3630Pacemaker generator function analyzer2
   870.3640Indirect pacemaker generator function analyzer2
   870.3720Pacemaker electrode function tester2
Miscellaneous870.1800Withdrawal-infusion pump2
   870.2800Medical magnetic tape recorder2
   NoneBatteries, rechargeable, class II devices
Dental Panel
Dental Equipment872.1720Pulp tester2
   872.1740Caries detection device2
   872.4120Bone cutting instrument and accessories2
   872.4465Gas-powered jet injector2
   872.4475Spring-powered jet injector2
   872.4600Intraoral ligature and wire lock2
   872.4840Rotary scaler2
   872.4850Ultrasonic scaler2
   872.4920Dental electrosurgical unit and accessories2
   872.6070Ultraviolet activator for polymerization2
   872.6350Ultraviolet detector2
Dental Material872.3050Amalgam alloy2
   872.3060Gold-based alloys and precious metal alloys for clinical use2
   872.3200Resin tooth bonding agent2
   872.3250Calcium hydroxide cavity liner2
   872.3260Cavity varnish2
   872.3275Dental cement (other than zinc oxide-eugenol)2
   872.3300Hydrophilic resin coating for dentures2
   872.3310Coating material for resin fillings2
   872.3590Preformed plastic denture tooth2
   872.3660Impression material2
   872.3690Tooth shade resin material2
   872.3710Base metal alloy2
   872.3750Bracket adhesive resin and tooth conditioner2
   872.3760Denture relining, repairing, or rebasing resin2
   872.3765Pit and fissure sealant and conditioner2
   872.3770Temporary crown and bridge resin2
   872.3820Root canal filling resin (other than chloroform use)2
   872.3920Porcelain tooth2
Dental X-ray872.1800Extraoral source x-ray system2
   872.1810Intraoral source x-ray system2
Dental Implants872.4880Intraosseous fixation screw or wire2
   872.3890Endodontic stabilizing splint2
Orthodontic872.5470Orthodontic plastic bracket2
Ear/Nose/Throat Panel
Diagnostic Equipment874.1050Audiometer2
   874.1090Auditory impedance tester2
   874.1120Electronic noise generator for audiometric testing2
   874.1325Electroglottograph2
   874.1820Surgical nerve stimulator/locator2
Hearing Aids874.3300Hearing aid (for bone-conduction)2
   874.3310Hearing aid calibrator and analysis system2
   874.3320Group hearing aid or group auditory trainer2
   874.3330Master hearing aid2
Surgical Equipment874.4250Ear, nose, and throat electric or pneumatic surgical drill1
   874.4490Argon laser for otology, rhinology, and laryngology2
   874.4500Ear, nose, and throat microsurgical carbon dioxide laser2
Gastroenterology/Urology Panel
Endoscope (including angioscopes, laparscopes, ophthalmic endoscopes)876.1500Endoscope and accessories2
   876.4300Endoscopic electrosurgical unit and accessories2
Gastroenterology876.1725Gastrointestinal motility monitoring system1
Hemodialysis876.5600Sorbent regenerated dialysate delivery system for hemodialysis2
   876.5630Peritoneal dialysis system and accessories2
   876.5665Water purification system for hemodialysis2
   876.5820Hemodialysis system and accessories2
   876.5830Hemodialyzer with disposable insert (kiil-type)2
Lithotriptor876.4500Mechanical lithotriptor2
Urology Equipment876.1620Urodynamics measurement system2
   876.5320Nonimplanted electrical continence device2
   876.5880Isolated kidney perfusion and transport system and accessories2
General Hospital Panel
Infusion Pumps and Systems880.2420Electronic monitor for gravity flow infusion systems2
   880.2460Electrically powered spinal fluid pressure monitor2
   880.5430Nonelectrically powered fluid injector2
   880.5725Infusion pump2
Neonatal Incubators880.5400Neonatal incubator2
   880.5410Neonatal transport incubator2
   880.5700Neonatal phototherapy unit2
Piston Syringes880.5570Hypodermic single lumen needle1
   880.5860Piston syringe (except antistick)1
   880.6920Syringe needle introducer2
Miscellaneous880.2910Clinical electronic thermometer2
   880.2920Clinical mercury thermometer2
   880.5100AC-powered adjustable hospital bed1
   880.5500AC-powered patient lift2
   880.6880Steam sterilizer (greater than 2 cubic feet)2
Neurology Panel
   882.1020Rigidity analyzer2
   882.1610Alpha monitor2
Neuro-Diagnostic882.1320Cutaneous electrode2
   882.1340Nasopharyngeal electrode2
   882.1350Needle electrode2
   882.1400Electroencephalograph2
   882.1460Nystagmograph2
   882.1480Neurological endoscope2
   882.1540Galvanic skin response measurement device2
   882.1550Nerve conduction velocity measurement device2
   882.1560Skin potential measurement device2
   882.1570Powered direct-contact temperature measurement device2
   882.1620Intracranial pressure monitoring device2
   882.1835Physiological signal amplifier2
   882.1845Physiological signal conditioner2
   882.1855Electroencephalogram (EEG) telemetry system2
   882.5050Biofeedback device2
Echoencephalography882.1240Echoencephalograph2
RPG882.4400Radiofrequency lesion generator2
Neuro SurgerynoneElectrode, spinal epidural2
   882.4305Powered compound cranial drills, burrs, trephines, and their accessories2
   882.4310Powered simple cranial drills burrs, trephines, and their accessories2
   882.4360Electric cranial drill motor2
   882.4370Pneumatic cranial drill motor2
   882.4560Stereotaxic instrument2
   882.4725Radiofrequency lesion probe2
   882.4845Powered rongeur2
   882.5500Lesion temperature monitor2
Stimulators882.1870Evoked response electrical stimulator2
   882.1880Evoked response mechanical stimulator2
   882.1890Evoked response photic stimulator2
   882.1900Evoked response auditory stimulator2
   882.1950Tremor transducer2
   882.5890Transcutaneous electrical nerve stimulator for pain relief2
Obstetrics/Gynecology Panel
Fetal Monitoring884.1660Transcervical endoscope (amnioscope) and accessories2
   884.1690Hysteroscope and accessories (for performance standards)2
   884.2225Obstetric-gynecologic ultrasonic imager2
   884.2600Fetal cardiac monitor2
   884.2640Fetal phonocardiographic monitor and accessories2
   884.2660Fetal ultrasonic monitor and accessories2
   884.2675Fetal scalp circular (spiral) electrode and applicator1
   884.2700Intrauterine pressure monitor and accessories2
   884.2720External uterine contraction monitor and accessories2
   884.2740Perinatal monitoring system and accessories2
   884.2960Obstetric ultrasonic transducer and accessories2
Gynecological Surgery Equipment884.1720Gynecologic laparoscope and accessories2
   884.4160Unipolar endoscopic coagulator-cutter and accessories2
   884.4550Gynecologic surgical laser2
   884.4120Gynecologic electrocautery and accessories2
   884.5300Condom2
Ophthalmic Implants886.3320Eye sphere implant2
Contact Lens886.1385Polymethylmethacrylate (PMMA) diagnostic contact lens2
   886.5916Rigid gas permeable contact lens (daily wear only)2
Diagnostic Equipment886.1120Opthalmic camera1
   886.1220Corneal electrode1
   886.1250Euthyscope (AC-powered)1
   886.1360Visual field laser instrument1
   886.1510Eye movement monitor1
   886.1570Ophthalmoscope1
   886.1630AC-powered photostimulator1
   886.1640Ophthalmic preamplifier1
   886.1670Ophthalmic isotope uptake probe2
   886.1780Retinoscope (AC-powered device)1
   886.1850AC-powered slit lamp biomicroscope1
   886.1930Tonometer and accessories2
   886.1945Transilluminator (AC-powered device)1
   886.3130Ophthalmic conformer2
(Diagnostic/Surgery Equipment)886.4670Phacofragmentation system2
Ophthalmic Implants886.3340Extraocular orbital implant2
   886.3800Scleral shell2
Surgical Equipment880.5725Infusion pump (performance standards)2
   886.3100Ophthalmic tantalum clip2
   886.3300Absorbable implant (scleral buckling method)2
   886.4100Radiofrequency electrosurgical cautery apparatus2
   886.4115Thermal cautery unit2
   886.4150Vitreous aspiration and cutting instrument2
   886.4170Cryophthalmic unit2
   886.4250Ophthalmic electrolysis unit (AC-powered device)1
   886.4335Operating headlamp (AC-powered device)1
   886.4390Ophthalmic laser2
   886.4392Nd:YAG laser for posterior capsulotomy2
   886.4400Electronic metal locator1
   886.4440AC-powered magnet1
   886.4610Ocular pressure applicator2
   886.4690Ophthalmic photocoagulator2
   886.4790Ophthalmic sponge2
   886.5100Ophthalmic beta radiation source2
   noneOphthalmoscopes, replacement batteries, hand-held1
Orthopedic Panel
Implants888.3010Bone fixation cerclage2
   888.3020Intramedullary fixation rod2
   888.3030Single/multiple component metallic bone fixation appliances and accessories2
   888.3040Smooth or threaded metallic bone fixation fastener2
   888.3050Spinal interlaminal fixation orthosis2
   888.3060Spinal intervertebral body fixation orthosis2
Surgical Equipment888.1240AC-powered dynamometer2
   888.4580Sonic surgical instrument and accessories/attachments2
   noneAccessories, fixation, spinal interlaminal2
   noneAccessories, fixation, spinal intervertebral body2
   noneMonitor, pressure, intracompartmental1
   noneOrthosis, fixation, spinal intervertebral fusion2
   noneOrthosis, spinal pedicle fixation
   noneSystem, cement removal extraction1
Physical Medicine Panel
Diagnostic Equipment or (Therapy) Therapeutic Equipment890.1225Chronaximeter2
   890.1375Diagnostic electromyograph2
   890.1385Diagnostic electromyograph needle electrode2
   890.1450Powered reflex hammer2
   890.1850Diagnostic muscle stimulator2
or (Therapy)890.5850Powered muscle stimulator2
Therapeutic Equipment890.5100Immersion hydrobath2
   890.5110Paraffin bath2
   890.5500Infrared lamp2
   890.5720Water circulating hot or cold pack2
   890.5740Powered heating pad2
Radiology Panel
MRI892.1000Magnetic resonance diagnostic device2
Ultrasound Diagnostic884.2660Fetal ultrasonic monitor and accessories2
   892.1540Nonfetal ultrasonic monitor
   892.1560Ultrasonic pulsed echo imaging system2
   892.1570Diagnostic ultrasonic transducer2
   892.1550Ultrasonic pulsed doppler imaging system
Angiographic892.1600Angiographic x-ray system2
Diagnostic X-Ray892.1610Diagnostic x-ray beam-limiting device2
   892.1620Cine or spot fluorographic x-ray camera2
   892.1630Electrostatic x-ray imaging system2
   892.1650Image-intensified fluoroscopic x-ray system2
   892.1670Spot film device2
   892.1680Stationary x-ray system2
   892.1710Mammographic x-ray system2
   892.1720Mobile x-ray system2
   892.1740Tomographic x-ray system1
   892.1820Pneumoencephalographic chair2
   892.1850Radiographic film cassette1
   892.1860Radiographic film/cassette changer1
   892.1870Radiographic film/cassette changer programmer2
   892.1900Automatic radiographic film processor2
   892.1980Radiologic table1
CT Scanner892.1750Computed tomography x-ray system2
Radiation Therapy892.5050Medical charged-particle radiation therapy system2
   892.5300Medical neutron radiation therapy system2
   892.5700Remote controlled radionuclide applicator system2
   892.5710Radiation therapy beam-shaping block2
   892.5730Radionuclide brachytherapy source2
   892.5750Radionuclide radiation therapy system2
   892.5770Powered radiation therapy patient support assembly2
   892.5840Radiation therapy simulation system2
   892.5930Therapeutic x-ray tube housing assembly1
Nuclear Medicine892.1170Bone densitometer2
   892.1200Emission computed tomography system2
   892.1310Nuclear tomography system1
   892.1390Radionuclide rebreathing system2
General/Plastic Surgery Panel
Surgical Lamps878.4630Ultraviolet lamp for dermatologic disorders2
   890.5500Infrared lamp2
   878.4580Surgical lamp2
Electrosurgical Cutting Equipment878.4810Laser surgical instrument for use in general and plastic surgery and in dermatology2
   878.4400Electrosurgical cutting and coagulation device and accessories2
Miscellaneous878.4780Powered suction pump2

1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.

[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]

Appendixes C-F to Subpart B of Part 26 [Reserved]

Subpart C—“Framework” Provisions

§26.60   Definitions.

(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.html. 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.

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.

(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.

(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.

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.

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.

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.

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.

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.

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.

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.

(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.

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.

(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.

(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.

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.

(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.

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.

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.

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.

(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.

(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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