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IDE Reports: Suggested Format for IDE Final Report

  1. Basic Elements
    • IDE Number
    • Device name and indication for use
    • Sponsor's name, address, phone number, and fax number
    • Contact person

  2. Study Progress. Data from beginning of the study should be reported, unless otherwise indicated.
    • Brief summary of study progress in relation to investigational plan
    • Number of investigators/investigational sites (attach list of investigators)
    • Number of subjects enrolled (by indication or model)
    • Number of devices shipped
    • Disposition of all devices shipped
    • Brief summary of results
    • Summary of anticipated and unanticipated adverse effects
    • Description of any deviations from the investigational plan by investigators (since last progress report)

  3. Risk Analysis
    • Summary of any new adverse information (since last progress report) that may affect the risk analysis; this includes preclinical data, animal studies, foreign data, clinical studies, etc.
    • Reprints of any articles published from data collected from this study

  4. Other Changes
    • Summary of any changes in manufacturing practices and quality control (including changes not reported in a supplemental application)
    • Summary of all changes in investigational plan not required to be submitted in a supplemental application

  5. Marketing Application or Future Plans
    • Progress toward product approval, with date (or projected date) of PMA or 510(k) submission; or indication that marketing of device is not planned.
    • Any plans to submit another IDE application for this device or a modification of this device.


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