Specific Sector Provisions for Medical Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. 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. Specific Sector Provisions for Medical Devices

Checkout our iOS App for a better way to browser and research.

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.

Appendix
Appendix A to Subpart B of Part 26

Relevant Legislation, Regulations, and Procedures.

Appendix
Appendix B to Subpart B of Part 26

Scope of Product Coverage

Appendix
Appendixes C-F to Subpart B of Part 26

Appendixes C-F to Subpart B of Part 26 [Reserved]

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.