[FDA approval description]

  1. IDE
    [Insert description]
    [Insert resources related to definition i.e., Learn More option]
    1. Feasibility Trial
      [Insert description]
      [Insert resources related to definition i.e., Learn More option]
      1. ISO 10993-1 (biocompatibility testing)
        [Insert description]
        [Insert resources related to definition i.e., Learn More option]
    2. Pivotal Trial
      [Insert description]
      [Insert resources related to definition i.e., Learn More option]
      1. Medicare IDE Pre-authorization
        [Insert description]
        [Insert resources related to definition i.e., Learn More option]
    3. Humanitarian Use Device
      [Insert description]
      [Insert resources related to definition i.e., Learn More option]
      1. Humanitarian Device Exemption
        [Insert description]
        Insert resources related to definition i.e., Learn More option]

Other Devices Sections

Patenting

Manufacturing

Regulatory Path to Market

Post-market

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.