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


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.

About the Author
Proxima CRO Team
Dora Huang

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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