21 C.F.R. § 26.63 General coverage of this part.
Title 21 - Food and Drugs
(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.
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
Subpart C—“Framework” Provisions
§ 26.63 General coverage of this part.
