Title 21

Appendix B to Subpart A of Part 26 - List of Authorities

21:1.0.1.1.20.1.63.22.2 : Appendix B

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 B to Subpart B of Part 26 - Scope of Product Coverage

21:1.0.1.1.20.2.63.21.7 : Appendix B

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.]