21 CFR Subpart B
Specific Sector Provisions for Medical Devices
June 25, 2020
§
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
A to Subpart B of Part 26
Relevant Legislation, Regulations, and Procedures
Appendix
B to Subpart B of Part 26
Scope of Product Coverage
Appendixes C-F to Subpart B of Part 26 [Reserved]
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