U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 26Subpart B - 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 Appendix A - Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.
Appendix Appendix B - Appendix B to Subpart B of Part 26—Scope of Product Coverage
Appendix - Appendixes C-F to Subpart B of Part 26 [Reserved]
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