Medical Device Design and Regulation

  1. Regulatory Submission Pathways
    1. Premarket Notification
      1. Substantial Equivalence
        1. Predicate Devices
          1. Traditional 510(k)
            1. Special 510(k)
              1. Abbreviated 510(k)
                1. Review Process and Timelines
                2. Premarket Approval
                  1. Requirements for Class III Devices
                    1. Demonstration of Safety and Efficacy
                      1. Modular and Staged PMA
                        1. Advisory Panel Review
                          1. Post-Approval Studies
                          2. De Novo Classification Request
                            1. Eligibility Criteria
                              1. Submission Process
                                1. Review and Decision
                                2. Humanitarian Device Exemption
                                  1. Definition and Purpose
                                    1. Application Process
                                      1. Limitations and Requirements

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                                    10. Clinical Evaluation and Trials

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                                    12. Labeling and Instructions for Use