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I am wondering if anyone has experience with developing the protocols for an IDE and can advise or direct me where to go to find information that would help my company to develop one.
We are considering doing an IDE on a device for Continuous Spinal Infusion but we are wondering how the FDA defines Continuous Spinal Infusion or Continuous Spinal Anesthesia/Anagesia?
We are considering doing an IDE on a device for Continuous Spinal Infusion but we are wondering how the FDA defines Continuous Spinal Infusion or Continuous Spinal Anesthesia/Anagesia?