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What does the FDA consider to be valid scientific evidence?

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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.

The study must contain evidence from the following: well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories, and reports of significant human experience with the device. The intended use of the IVD, level and quality of information in literature relevant to device use, and FDA knowledge of technology obtained from reviewing other premarket applications will be used to determine the type of study and level of evidence you need to demonstrate reasonable assurance of safety and effectiveness.

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