Medical Device Design and Regulation

  1. Labeling and Instructions for Use
    1. Regulatory Requirements for Labeling
      1. FDA Labeling Requirements
        1. EU MDR Labeling Requirements
        2. Content of the Instructions for Use
          1. Intended Use and Indications
            1. Contraindications
              1. Warnings and Precautions
                1. Instructions for Use
                  1. Maintenance and Storage
                  2. Symbols for Medical Device Labeling
                    1. Commonly Used Symbols
                      1. Interpretation and Application
                      2. Unique Device Identification
                        1. UDI System Structure
                          1. Labeling Requirements
                            1. Database Requirements

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                          11. Regulatory Submission Pathways

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                          13. Post-Market Surveillance and Activities