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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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