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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER A—GENERAL
  6. 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
  7. Subpart B—Specific Sector Provisions for Medical Devices

21 CFR Part 26 - Subpart B - Specific Sector Provisions for Medical Devices

  • CFR
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  1. § 26.31 Purpose.
  2. § 26.32 Scope.
  3. § 26.33 Product coverage.
  4. § 26.34 Regulatory authorities.
  5. § 26.35 Length and purpose of transition period.
  6. § 26.36 Listing of CAB's.
  7. § 26.37 Confidence building activities.
  8. § 26.38 Other transition period activities.
  9. § 26.39 Equivalence assessment.
  10. § 26.40 Start of the operational period.
  11. § 26.41 Exchange and endorsement of quality system evaluation reports.
  12. § 26.42 Exchange and endorsement of product evaluation reports.
  13. § 26.43 Transmission of quality system evaluation reports.
  14. § 26.44 Transmission of product evaluation reports.
  15. § 26.45 Monitoring continued equivalence.
  16. § 26.46 Listing of additional CAB's.
  17. § 26.47 Role and composition of the Joint Sectoral Committee.
  18. § 26.48 Harmonization.
  19. § 26.49 Regulatory cooperation.
  20. § 26.50 Alert system and exchange of postmarket vigilance reports.
  21. Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.
  22. Appendix B to Subpart B of Part 26—Scope of Product Coverage
  23. Appendixes C-F to Subpart B of Part 26 [Reserved]

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