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UT Health Sponsored Projects Administration COVERAGE ANALYSIS Principal Investigator: Coordinator: Study Title: IRB #: NCT #: Sponsor: Device Studies IDE A IDE B 510K What type of device is being
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Device studies at a university involve researching and testing medical devices to ensure their safety and effectiveness.
Universities conducting device studies are required to file reports with regulatory authorities.
Device studies at universities must be filled out accurately with all relevant information regarding the research and testing being conducted.
The purpose of device studies at universities is to ensure the safety and effectiveness of medical devices before they are used on patients.
Information such as study protocols, participant information, results, and any adverse events must be reported on device studies at universities.
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