Skip to content
LexBuild

21 CFR § 26.34 - Regulatory authorities.

---
identifier: "/us/cfr/t21/s26.34"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 26.34 - Regulatory authorities."
title_number: 21
title_name: "Food and Drugs"
section_number: "26.34"
section_name: "Regulatory authorities."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "26"
part_name: "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"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "63 FR 60141, Nov. 6, 1998, unless otherwise noted."
cfr_part: "26"
---

# 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.