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Are there different goals for IVD studies compared to other device studies?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

No, the goals for IVD studies are the same as the goals for other device studies, even if the IVD study is exempt from IDE requirements. The FDA recommends that the sponsor and the investigators conduct an IVD device study with the goals of…

  • Producing valid scientific evidence demonstrating reasonable assurance of the safety and effectiveness of the product, and
  • Protecting the rights and welfare of study subjects.

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