Subpart B - SPECIFIC sectOR PROVISIONS FOR MEDICAL DEVICES
- Appendix A to Subpart B of Part 26 - Relevant Legislation, Regulations, and Procedures
- Appendix B to Subpart B of Part 26 - Scope of Product Coverage
- Section 26.31 - Purpose
- Section 26.32 - Scope
- Section 26.33 - Product coverage
- Section 26.34 - Regulatory authorities
- Section 26.35 - Length and purpose of transition period
- Section 26.36 - Listing of CAB's
- Section 26.37 - Confidence building activities
- Section 26.38 - Other transition period activities
- Section 26.39 - Equivalence assessment
- Section 26.40 - Start of the operational period
- Section 26.41 - Exchange and endorsement of quality system evaluation reports
- Section 26.42 - Exchange and endorsement of product evaluation reports
- Section 26.43 - Transmission of quality system evaluation reports
- Section 26.44 - Transmission of product evaluation reports
- Section 26.45 - Monitoring continued equivalence
- Section 26.46 - Listing of additional CAB's
- Section 26.47 - Role and composition of the Joint Sectoral Committee
- Section 26.48 - Harmonization
- Section 26.49 - Regulatory cooperation
- Section 26.50 - Alert system and exchange of postmarket vigilance reports
- Appendix C-F to Subpart B of Part 26 - Reserved