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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Investigational Device Exemption (IDE)
  7. IDE Regulations
  1. Investigational Device Exemption (IDE)

IDE Regulations

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